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We present the results of a feasibility, randomized waitlist control group (CG) parallel design study with a 1:1 allocation ratio. Participants were randomized into an intervention group (IG) or a waitlist CG. The intervention was a 6-week digital self-management program, Help to Overcome Problems Effectively (HOPE), for people with cancer.
This study aims to test the feasibility of a digitally delivered self-management program for people with cancer. This will inform the design of a definitive randomized controlled trial. In addition, a preliminary assessment of the impact of the HOPE program via secondary outcomes will be used to assess signals of efficacy in a trial context.
Participants were drawn from an opportunity sample, referred by Macmillan Cancer Support, and were invited via email to participate in the study (N=61). Primary outcomes were rates of recruitment, retention, follow-up, completion and adherence, sample size and effect size estimation, and assessment of progression criteria for a definitive trial. Secondary outcomes were self-report measures of participants’ positive mental well-being, depression, anxiety, and patient activation (ie, confidence in managing their cancer). The intervention and data collection took place on the web.
The recruitment rate was 77% (47/61). A total of 41 participants completed the baseline questionnaires and were randomized to either the IG (n=21) or the waitlist CG (n=20). The retention rate (attending all program sessions) was greater than 50% (all: 21/41, 51%, IG: 10/21, 48%; and CG: 11/20, 55%). The follow-up rate (completing all questionnaires) was greater than 80% (all: 33/41, 80%; IG: 16/21, 76%; and CG: 17/20, 85%). The completion rate (attending ≥3 sessions and completing all questionnaires) was greater than 60% (all: 25/41, 61%; IG: 13/21, 62%; and CG: 12/20, 60%). Engagement data showed that participants viewed between half (5.1/10, 51%) and three-quarters (12.2/16, 76%) of the pages in each session.
All progression criteria for a definitive trial were met, as supported by the primary outcome data. The IG showed improved postprogram scores on measures of positive mental well-being, depression, anxiety, and patient activation. A full-scale trial of the digital HOPE program for people with cancer will allow us to fully evaluate the efficacy of the intervention relative to a CG.
ISRCTN Registry ISRCTN79623250; http://www.isrctn.com/ISRCTN79623250
RR2-10.2196/24264
As of May 2021, the United Kingdom has seen 3 periods of national lockdown and widespread social and physical distancing measures implemented by the government in an attempt to curtail the spread of SARS-CoV-2. Such measures have resulted in significant reductions in the delivery of cancer services in the United Kingdom, as pressures on health services, lockdown demands, and the need to reduce face-to-face interactions have taken precedence [
People with cancer are already known to face multiple challenges in terms of mental and physical health following primary treatment, including fatigue, pain, sexual problems, cognitive functioning, depression, anxiety, social isolation, and financial issues [
Before the COVID-19 pandemic, there was a shortage of accessible self-management interventions, and there was an even greater need for digital interventions to comply with social distancing guidelines. Around a decade ago, we co-designed a face-to-face self-management program for survivors of all types of cancer [
This study aims to test the feasibility of a digitally delivered self-management program for people with cancer. This will inform the design of a definitive RCT. In addition, a preliminary assessment of the impact of the HOPE program via secondary outcomes will be used to assess signals of efficacy in a trial context.
The planned primary outcomes (trial feasibility objectives) of the study were as follows: (1) recruitment rates for participation and for randomization; (2) retention and follow-up rates as the participants move through the trial; (3) adherence rates to study procedures, intervention attendance, and engagement; (4) sample size and effect size estimation for a definitive trial; and (5) progression criteria for a definitive trial.
The secondary outcomes related to participant well-being are measures of positive mental well-being, depression, anxiety, and confidence in self-managing cancer (patient activation), as indicated by scores on validated measures.
The following sections were written in accordance with the 2016 CONSORT (Consolidated Standards of Reporting Trials) extension for pilot and feasibility trials [
This study used a feasibility, randomized waitlist control group (CG) parallel design, with a 1:1 allocation ratio. Participants were randomized into an intervention group (IG) or a waitlist CG. The IG received access to the digital 6-week HOPE program immediately. The CG was placed on a waiting list for approximately 6 weeks, after which time they also received access to the same digital 6-week HOPE program. Key outcome measures were collected via web-based questionnaires at time 0 (T0; baseline) and time 1 (T1; 6 weeks postrandomization and postprogram for IG). We also sent the questionnaires to the CG only again after they had received the intervention (time 2; T2; postprogram for CG).
The participants were referred by MCS, a leading UK cancer charity. They advertise the HOPE program through their social media networks, MCS websites, and word-of-mouth through specialist nurses.
Eligibility criteria for participants were as follows: (1) any cancer diagnosis, at any treatment stage; (2) adult (18 years or older), (3) located in the United Kingdom; (4) access to the internet and a device that allows them to engage with the intervention; and (5) fluent in English to be able to engage with all the material in the intervention.
All study data were collected on the web via questionnaires administered through the Qualtrics Survey Software (Qualtrics 2019; [
All participants had access to the same digital HOPE program. The IG received access immediately, and the CG was granted access approximately 6 weeks later.
The HOPE program was delivered on the web. Full details of the digital HOPE program development, content, and weekly topics have been described elsewhere (see [
Examples of content, exercises, and activities within each weekly module of the Help to Overcome Problems Effectively program.
Session | Examples of content | Examples of exercises and activities (self-management tools) |
Week 1 (Introduction or instilling hope) |
Aims of the program User guide to navigating the platform and setting up a profile Introduction to self-management The benefits of positive emotions Video (Positive emotions for a flourishing life) The power of gratitude Personalized goal-setting Video (How to set achievable goals) Forum topic (Reasons for joining the program) Further resources and links (eg, videos, podcasts, and websites) to gratitude, positivity, and goal-setting |
Interactive gratitude diary SMARTERa goal-setting Assessment: positivity ratio test and positive and negative emotions test |
Week 2 (Stress management) |
Understanding stress Managing stress Videos (How to manage stress and how to make stress your friend) Coping with unhelpful thinking patterns Mindfulness for stress management and meditation Self-compassion and acceptance Video (How to be kind to yourself) Forum topic (How do you deal with cancer-related stress?) Further resources and links (eg, videos, podcasts, and websites) to self-compassion, mindfulness, and stress management |
Interactive gratitude diary SMARTER goal-setting and goal feedback Guided relaxation and meditation exercise (podcasts) How to cope with unhelpful thoughts (worksheet) |
Week 3 (Managing fatigue) |
Understanding the boom and bust cycle Using the 3 Ps (prioritizing, planning, and pacing) for managing fatigue Video (Tips for managing fatigue) Sleeping better; podcast: Tips to improve sleep Forum topic (Coping with fatigue) Further resources and links (eg, videos, podcasts, and websites) to sleeping better |
Interactive gratitude diary SMARTER goal-setting and goal feedback Fatigue and pacing diaries (worksheets) Quiz (What are the main challenges faced by cancer survivors?) |
Week 4 (Body image and communication) |
Body image Video (Body image and cancer) Sexuality and intimacy Video (Cancer as a passport to emotional intimacy) Communication skills and tips for talking with the health care team and family Forum topic: experiences of coping with body changes and experiences of communicating with the health care team Further resources and links (eg, videos, podcasts, and websites) to sexuality, intimacy, and relationships |
Interactive gratitude diary SMARTER goal-setting and goal feedback |
Week 5 (Physical activity and fear of recurrence) |
Coping with fear of recurrence Videos (Moving forward while being worried about cancer returning and the regrets of those who are dying) Hopes and dreams for the future Video: Before I die project The benefits of physical activity Video (Tips for becoming and staying active) Forum topic (Concerns about cancer coming back) Further resources and links (eg, videos, podcasts, and websites) to managing concerns about cancer coming back and getting more active |
Interactive gratitude diary SMARTER goal-setting and goal feedback |
Week 6 (Character strengths and happiness) |
Understanding how using your strengths can lead to a more fulfilling life Video (The science of character strengths) Tips for authentic happiness; managing setbacks and keeping going Forum topic (Learning from the program) Further resources and links (eg, videos, podcasts, and websites) to MCSb web-based communities and happiness resources |
Interactive gratitude diary SMARTER goal-setting and goal feedback Assessment (positivity ratio test and positive and negative emotions test and character strengths) Quiz (What contributes to happiness?) |
aSMARTER: SMARTER is an acronym used by many organizations for goal-setting, and stands for specific, measurable, achievable, relevant, time-bound, enjoyable, and reward.
bMCS: Macmillan Cancer Support.
The primary outcome measures for this feasibility RCT were as follows:
Recruitment rates for participation and randomization were collected primarily through Qualtrics at the start of the trial. All eligible participants identified by MCS were sent a link to the Qualtrics study survey. Recruitment rates were then calculated from the following: (1) providing consent and (2) completing baseline questionnaires. Direct email from participants indicating refusal or declining to participate in the study indicated a refusal. These participants were still offered access to the HOPE program but did not participate in any further data collection.
The participant retention rate was calculated as the percentage of participants attending all 6 program sessions. Studies show that a median of 56% of participants complete the full program in digital interventions for mental well-being [
Follow-up was calculated as the percentage of participants who completed all web-based study questionnaires. Participants who were lost to follow-up were identified through Qualtrics as those who did not complete the postprogram questionnaires at the end of the intervention period. It is possible that these participants may still have attended some portions or the entire HOPE program, despite not completing questionnaires.
If participants attended at least half of the intervention (3 sessions) [
The intervention platform collects user engagement data, such as the number of pages viewed in each session and the number of goals set that assists the moderators with participant engagement and experience. We measured the mean percentage of pages viewed per session, and the number of posts or comments a participant made for key activities (gratitude, setting goals, goal feedback, liking posts, and comments posted).
To inform the sample size estimation for a future definitive trial, we calculated the SDs of key continuous secondary outcomes at baseline. To estimate potential effect sizes for a primary outcome in a future definitive trial from pre- to postprogram, we calculated the difference between the mean difference pre- and postprogram for the IG and CG and divided by the pooled SD at baseline [
There is little guidance available for determining progression criteria for exploratory studies, including feasibility trials [
To inform the progression to a definitive trial, we compared our results to the progression criteria set
Sociodemographic and health data were collected at T0. Participants were asked to provide the following information via a web-based questionnaire: gender, age, ethnicity, marital status, highest level of education, employment and occupation, and details about their cancer diagnosis and other medical conditions.
Participants completed a set of validated questionnaires at T0 (baseline), T1 (6 weeks postrandomization), and T2 (postprogram for CG only). Postprogram (T1 and T2) questionnaires were made available to participants the week after the intervention ended and remained available for a further 4 weeks. The positive mental well-being, depression, anxiety, and patient activation measures are detailed below.
The Warwick Edinburgh Mental Well-being Scale (WEMWBS) [
The 9-item Patient Health Questionnaire (PHQ-9) [
Responses to each of the 9 items ranged from 0 to 3 (0=not at all, 1=several days, 2=more than half the days, 3=nearly every day), leading to a summed score between 0 and 27, with higher scores indicating greater severity of depression. The PHQ-9 has good internal consistency (α=.89). Scores of 10 or more are presumed to be above the clinical range; thus, participants scoring 10 are categorized as depressed for the purpose of this study.
The 7-item Generalized Anxiety Disorder scale (GAD-7) [
The Patient Activation Measure [
Level 1 (scores ≤47.0): Individuals tend to be passive and feel overwhelmed by managing their own health. They may not understand their roles in the care process.
Level 2 (scores 47.1-55.1): Individuals may lack the knowledge and confidence to manage their health.
Level 3 (scores 55.2-67.0): Individuals appear to be taking action but may still lack the confidence and skill to support their behaviors.
Level 4 (scores 67.1): Individuals have adopted many of the behaviors needed to support their health but may not be able to maintain them in the face of life stressors.
All study participants were drawn from an opportunity sample (N=61), provided by MCS, of eligible candidates who expressed an interest in taking part in the HOPE program. An arbitrary sample size of n=40 was deemed adequate for this feasibility study, informed by similar studies in this area, with sample sizes ranging from 10 to 20 in each arm [
All participants who provided informed consent and completed the T0 questionnaires were randomized into the IG or CG using a 1:1 ratio via the randomization function within the Qualtrics Survey Software.
Participants were informed on completion of the T0 questionnaires, via a notification in Qualtrics, whether they had been randomized to the IG (in this case, starting in May 2020), or the CG (in this case, starting in June 2020). The research team remained unaware of participant allocation until group contact lists were created at the next data collection point (ie, T1).
Participants were allocated to the IG or CG via the randomization function in Qualtrics. Participants were then emailed with a link to the HOPE program starting in the following week (IG), or a message to say that they would be emailed a link to the HOPE program (CG) in approximately 6 weeks’ time.
Owing to the nature of the study design, it was not possible to blind the participants to their group allocation. However, statistical analyses of study data were conducted blind to participant allocation where possible (eg, IG and CG were labeled
Quantitative data were analyzed descriptively using IBM SPSS 26 (IBM Corporation, released 2019). Initial analyses involved tabulated and graphical summaries of primary and secondary outcomes for each randomized group using means and variance, including CIs and SDs, and number and percentages for categorical variables to describe the full range of data at baseline and postprogram. An intention-to-treat (ITT) analysis was carried out, where missing data were rectified using the last observation carried forward (LOCF) [
The study was not powered to perform inferential statistical analyses, and so to signal efficacy, we report pre- and postprogram mean differences and CIs for scores on key secondary outcome measures for the IG and CG.
The feasibility trial protocol has been registered and published (International Registered Report Identifier IRRID: DERR1-10.2196/24264) [
Participant flow through the study. HOPE: Help to Overcome Problems Effectively.
Recruitment started on April 30, 2020, and ended on May 5, 2020. Data collection started on April 30, 2020, for T0 baseline questionnaires and finished on September 2, 2020, for T2 follow-up questionnaires (CG only), which was 4 weeks after the end of the intervention for the CG as specified in the trial protocol.
Sociodemographic and health information collected at baseline (T0) for the whole group and by treatment group are presented in
Baseline characteristics for the whole sample and by trial arm.
Variable | All (N=41) | IGa (n=21) | CGb (n=20) | ||||
Age, mean (SD) | 54.3 (11) | 52.6 (11) | 56.2 (12) | ||||
Female, n (%) | 32 (78) | 17 (81) | 15 (75) | ||||
White ethnicity, n (%) | 36 (88) | 19 (90) | 17 (85) | ||||
Married or living with partner, n (%) | 30 (73) | 17 (81) | 13 (65) | ||||
Employed, n (%) | 21 (51) | 11 (52) | 10 (50) | ||||
Cut work hours due to cancer, n (%) | 20 (49) | 14 (67) | 6 (30) | ||||
Possessed postschool qualifications, n (%) | 24 (58) | 12 (57) | 12 (60) | ||||
Still undergoing treatment for cancer, n (%) | 17 (41) | 9 (43) | 8 (40) | ||||
|
|||||||
|
Breast | 17 (41) | 8 (38) | 9 (45) | |||
|
Gynecological | 4 (10) | 0 (0) | 4 (20) | |||
|
Prostate | 2 (5) | 0 (0) | 2 (10) | |||
|
Lung | 3 (7) | 2 (9) | 1 (5) | |||
|
Colorectal | 3 (7) | 3 (14) | 0 (0) | |||
|
Gastrointestinal | 2 (5) | 0 (0) | 2 (10) | |||
|
Bladder or kidney | 1 (2) | 0 (0) | 1 (5) | |||
|
Head or neck | 4 (19) | 2 (9) | 2 (5) | |||
|
Other | 9 (22) | 8 (38) | 1 (5) |
aIG: intervention group.
bCG: control group.
The total number of participants enrolled in the study was 41, with 21 in the IG and 20 in the CG. All participants completed baseline (T0) questionnaires, and missing data in T1 and T2 questionnaires were populated with the LOCF method for ITT analysis. Therefore, the entire sample was included in the ITT analysis (ITT, N=41; IG, n=21; CG, n=20). The numbers for the PP analysis are detailed in the
We describe the results for each primary and secondary outcome. Primary outcome measures pertaining to recruitment, questionnaire, and intervention completion rates are presented in
Number of participants who attended none, some, or all of the Help to Overcome Problems Effectively Program sessions, for the whole group and each trial arm.
Number of sessions attended | All (N=41), n (%) | IGa (n=21), n (%) | CGb (n=20), n (%) |
0 | 5 (12) | 2 (9) | 3 (15) |
1 | 5 (12) | 3 (14) | 2 (10) |
2 | 5 (12) | 3 (14) | 2 (10) |
3 | 2 (5) | 1 (5) | 1 (5) |
4 | 1 (2) | 0 (0) | 1 (5) |
5 | 2 (5) | 2 (9) | 0 (0) |
6 | 21 (51) | 10 (47) | 11 (55) |
aIG: intervention group.
bCG: control group.
An overview of engagement and adherence with the Help to Overcome Problems Effectively Program, for the whole group and by trial arm.
Engagement measure | All (N=41), |
All (n=41), |
IGa (n=21), |
IG (n=21), |
CGb (n=20), |
CG (n=20), |
Mean pages viewed in session 1 |
12.2 (76) | 12.2 (6.4) | 12.2 (76) | 12.2 (6.2) | 12.2 (76) | 12.2 (6.7) |
Mean pages viewed in session 2 |
8.5 (65) | 8.5 (6.0) | 8.0 (61) | 8.0 (6.1) | 9.1 (70) | 9.1 (6.0) |
Mean pages viewed in session 3 |
10.3 (60) | 10.3 (8.0) | 9.7 (57) | 9.7 (8.0) | 10.9 (64) | 10.9 (8.2) |
Mean pages viewed in session 4 |
7.5 (53) | 7.5 (6.8) | 7.0 (50) | 7.0 (7.0) | 8.1 (58) | 8.1 (6.9) |
Mean pages viewed in session 5 |
8.2 (51) | 8.2 (8.0) | 7.7 (48) | 7.7 (8.0) | 8.8 (55) | 8.8 (8.2) |
Mean pages viewed in session 6 |
5.1 (51) | 5.1 (4.6) | 5.0 (50) | 5.0 (4.4) | 5.3 (53) | 5.3 (4.9) |
Gratitude entries across whole program |
N/Ac | 1.5 (1.9) | N/A | 1.3 (1.3) | N/A | 1.7 (2.4) |
Goals set across whole program |
N/A | 2.1 (2.1) | N/A | 1.8 (1.8) | N/A | 2.4 (2.4) |
Goal feedback given across whole |
N/A | 0.5 (1.1) | N/A | 0.4 (1.0) | N/A | 0.7 (1.2) |
Likes given across whole program |
N/A | 6.8 (12.2) | N/A | 3.8 (6.6) | N/A | 10.0 (15.8) |
Comments posted across whole |
N/A | 6.8 (9.9) | N/A | 5.8 (9.2) | N/A | 7.9 (10.7) |
aIG: intervention group.
bCG: control group.
cN/A: not applicable.
All scores, intention-to-treat, on secondary outcome measures for intervention control (IG) and control group (CG), and change in scores (T1-T0), and mean difference in changes scores (IG-CG).
Secondary outcome measure | IG (n=21) | CG (n=20) | Difference in change scores Δ IG-CG, mean difference (95% CI) | ||||||
|
T0, mean (SD) | T1a, mean (SD) | Postprogram change Δ (T1-T0), mean difference (95% CI) | T0, mean (SD) | T1b, mean (SD) | Control change Δ (T1-T0), mean difference (95% CI) |
|
||
WEMWBSc | 43.3 (9.6) | 46.3 (11.7) | 3.0 (−0.2 to 6.2) | 43.4 (12.4) | 45.1 (11.8) | 1.7 (−1.6 to 5.0) | 1.3 (−3.1 to 5.7) | ||
PHQ-9d | 10.0 (5.4) | 8.1 (5.7) | −1.8 (−3.3 to −0.4) | 9.2 (6.3) | 9.3 (6.5) | 0.1 (−2.0 to 2.2) | −1.9 (−4.4 to 0.6) | ||
GAD-7e | 8.8 (5.6) | 7.6 (5.6) | −1.2 (−3.0 to 0.6) | 9.0 (6.6) | 7.4 (4.8) | −1.6 (−3.7 to 0.5) | 0.4 (−2.2 to 3.1) | ||
PAMf | 58.8 (17.2) | 60.8 (17.2) | 2.0 (0.1 to 3.9) | 61.3 (15.3) | 59.1 (14.2) | −2.2 (−6.6 to 2.2) | 4.2 (−0.3 to 8.7) |
aLOCF: last observation carried forward, n=5.
bLOCF: last observation carried forward, n=3.
cWEMWBS: Warwick-Edinburgh Mental Well-being Scale.
dPHQ-9: 9-item Patient Health Questionnaire.
eGAD-7: 7-item Generalized Anxiety Disorder scale.
fPAM: Patient Activation Measure.
The recruitment rate for this feasibility study was 77% (47/61). MCS referred to 61 participants for the study, and 77% of participants (47/61) provided digital informed consent. Only participants who (1) consented, (2) completed baseline questionnaires, and (3) were randomized, were included in this feasibility study (n=41). Six participants provided informed consent but did not complete the T0 questionnaire; therefore, they were not randomized (6/47, 13%). The study participants who completed the baseline questionnaires (n=41) were randomized to either the IG (n=21) or the CG (n=20) groups.
The retention rate across the sample was 51%, with more than half of the participants attending all 6 program sessions (whole group: 21/41, 51%; IG: 10/21, 47%; CG: 11/20, 55%).
Across the whole group, there was a follow-up rate of 80% (33/41 participants completed T1 questionnaires). Across the trial arms, the follow-up rate was 76% (16/21) in the IG and 85% (17/20) in the CG.
The completion rates (3 sessions and T1 questionnaire) for the whole group were 61% (25/41), 62% (13/21) in the IG, and 60% (12/20) in the CG.
To guide the sample size estimation for a future definitive trial, we used the results of this study. Accordingly, we calculated the expected minimum effect sizes using the primary outcome variable, WEMWBS, and based on the present data, considering the mean change scores for IG and CG and a moderate between-group effect size. Given an
All predetermined progression criteria for a definitive trial were met, as described in the sections above.
An ITT analysis was carried out, with missing data rectified by LOCF. The mean scores and SDs for the secondary outcome measures for both trial arms are presented in
Proportion of participants reporting probable clinical levels of depression and anxiety at each time point across the trial.
Secondary outcome measure | IGa, n (%); n=21 | CGb, n (%); n=20 | |||
|
T0 | T1c | T0 | T1d | T2e |
Cases of probable depression | 8 (38) | 7 (33) | 10 (50) | 7 (35) | 4 (20) |
Cases of probable clinical anxiety | 10 (47) | 10 (47) | 10 (50) | 8 (40) | 5 (25) |
aIG: intervention group.
bCG: control group.
cLOCF: last observation carried forward, n=5.
dLOCF: last observation carried forward, n=3.
eLOCF: last observation carried forward, n=6.
We conducted a PP analysis, which included only those participants who completed all study questionnaires and attended at least 3 intervention sessions (PP whole sample n=25; IG n=13, CG n=12).
Scores on secondary outcome measures for intervention group (IG; n=13) and control group (CG; n=12) intervention completers (PP), including mean difference in change scores (IG-CG).
Secondary outcome measure | IG (n=13) | CG (n=12) | Difference in change scores Δ IG-CG, mean difference (95% CI) | ||||||
|
T0, mean (SD) | T1, mean (SD) | Postprogram change Δ (T1-T0), mean difference (95% CI) | T0, mean (SD) | T1, mean (SD) | Control change Δ (T1-T0), mean difference |
|
||
WEMWBSa | 44.9 |
49.5 |
4.6 (−0.5 to 9.7) | 43.8 |
42.7 (11.7) | −1.1 (−4.7 to 2.5) | 5.7 (−0.3 to 11.7) | ||
PHQ-9b | 9.1 |
6.8 |
−2.2 (−4.3 to −0.2) | 9.1 |
10.8 (6.7) | 1.7 (0.4 to 2.9) | −3.9 (−6.2 to −1.6) | ||
GAD-7c | 8.6 |
7.0 |
−1.6 (−4.4 to 1.2) | 8.5 |
8.8 (4.8) | 0.3 (−1.8 to 2.3) | −1.9 (−5.2 to 1.5) | ||
PAMd | 63.2 |
66.2 |
3.0 (0 to 6.0) | 61.6 |
56.1 (11.2) | −5.5 (−11.7 to 0.7) | 8.5 (2.2 to 14.8) |
aWEMWBS: Warwick-Edinburgh Mental Well-being Scale.
bPHQ-9: 9-item Patient Health Questionnaire.
cGAD-7: 7-item Generalized Anxiety Disorder scale.
dPAM: Patient Activation Measure.
In line with the trial protocol [
As detailed in the Methods section, participants scoring 10 on the PHQ-9 or 8 on the GAD-7 were categorized as having reached a probable clinical level of depression or anxiety, respectively. Depression was indicated in 44% (18/41) of participants at preprogram and 34% (14/41) at T1. Anxiety was indicated in 49% (20/41) of participants at preprogram and 44% (18/41) at T1. In line with the trial protocol [
At postprogram, there were no participants who reported a probable clinical level of depression where they had not already reported this at the preprogram. However, at postprogram, 5% (2/41) of participants reached a probable clinical level of anxiety but were not previously at this level in the preprogram. Both participants scored 7 on the GAD-7 measure at preprogram, increasing to scores of 8 (n=1) and 9 (n=1) at postprogram. Both participants were contacted by H4C, as outlined above, and in the trial protocol [
The feasibility RCT of the digital HOPE program aimed to assess primary outcomes measuring trial feasibility and secondary outcomes relating to measures of participant well-being. The trial yielded encouraging data on the primary outcome measures of recruitment, retention, follow-up, adherence, and engagement rates. More than three-quarters of the participants invited (47/61, 77%) were willing to provide consent and be randomized to either the HOPE program starting the following week, or to a 6-week waiting list. Just over half of the sample (ie, IG and CG combined; 21/41, 51%) completed all 6 sessions of the intervention, and almost two-thirds of the sample (26/41, 63%) completed at least 3 sessions (note that n=1 did not complete the T1 questionnaire, so it was not categorized as an intervention completer. The follow-up rate was encouraging, with a large proportion of participants completing the study questionnaires at T1 (33/41, 80%). Of the participants who completed the T1 questionnaires, 25 also attended 3 intervention sessions, meeting the criteria for intervention completion (25/41, 61%). In terms of engagement, within the sessions, participants viewed between half and three-quarters of the content, on average (range 76%-51%). All of the predetermined progression criteria were met, confirming that a full-scale, fully powered RCT of the digital HOPE program for people with cancer would be feasible.
On average, participants showed increased scores on positive mental well-being and patient activation and decreased scores on anxiety and depression at postprogram relative to baseline. We did not ask participants specific questions relating to their well-being during the COVID-19 pandemic. However, we can tentatively compare data from this study with a previous cohort of people with cancer in the digital HOPE program, collected before the COVID-19 pandemic [
Exploration of the secondary outcome data highlights the safety of the HOPE program as a digital self-management intervention for people with cancer. There were no cases of participants reporting increased symptoms of depression, and only 2 participants reported increased postprogram anxiety. There were no cases where participants reported thoughts of suicide or harming themselves at postprogram, where they had not already reported this at baseline.
This study found that overall engagement, measured by the percentage of pages viewed, seemed to decline as participants progressed through the sessions. This may be due to fatigue or redundant content. Qualitative investigation into what content participants engaged with, and elements they found more or less relevant or helpful would be a useful supplement to improve the intervention.
This feasibility RCT was not powered to detect statistically significant differences in pre- and postscores on secondary outcomes. However, the results indicate that the HOPE program has the potential to have a positive effect on mental well-being, depression, and anxiety in people with cancer. These have been identified as important outcomes for people with cancer [
The recruitment for this feasibility RCT was from an opportunity sample of self-selecting participants referred by MCS. The self-selecting nature of the recruitment strategy may yield participants who are generally more motivated to seek help and/or help themselves. However, this recruitment strategy facilitated the rapid attainment of trial recruitment targets in this study [
Most participants were White (36/41, 88%), female (32/41, 78.0%), married (30/41, 73%), and educated (24/41, 58%), and the most commonly reported type of cancer was breast cancer (17/41, 41%). This likely relates to the demographics of people who engage with the MCS charity. Although this may limit the generalizability of the results to other demographic groups, some aspects are in line with wider population statistics and research findings. The 2011 Census [
A low attendance rate for men is common in self-management and is linked to their reluctance to seek help [
The digital HOPE program is a feasible self-management intervention for people with cancer, although almost half of our sample comprised people with breast cancer. All progression criteria were met, providing support for a full-scale definitive trial. However, caution must be taken when interpreting the generalizability of our feasibility estimates, and a further discussion with our research trial group will be undertaken to determine the appropriate action for progression. Generally, at postprogram, all participants showed increased scores on positive mental well-being and patient activation and decreased scores on anxiety and depression relative to baseline, signaling intervention efficacy. Minimal harm was indicated, and no participants reported postprogram symptoms of anxiety or depression that were not present at baseline, and similarly for thoughts of suicide and self-harm.
The asynchronous nature of the course and the autonomy afforded to participants means that they can broadly tailor the course to accommodate personal needs. Participants can attend sessions that are interesting or relevant to them, essentially creating their own person-centered support by self-selecting the content. Rather than interpreting attrition as a negative trial outcome, we concur with the view that participants can be
The advent of the digital HOPE program has coincided with requests from academics, leading cancer charities, and the NHS, for more person-centered cancer self-management, especially during the recent global pandemic [
CONSORT-eHEALTH checklist (V 1.6.1).
control group
Consolidated Standards of Reporting Trials
7-item Generalized Anxiety Disorder scale
Hope for the Community
Help to Overcome Problems Effectively
intervention group
intention-to-treat
last observation carried forward
Macmillan Cancer Support
National Health Service
9-item Patient Health Questionnaire
per-protocol
randomized controlled trial
Warwick Edinburgh Mental Well-being Scale
The research study was investigator funded and approved by the Coventry University Ethics Committee (P106024) on April 28, 2020.
AT is the co-inventor of the HOPE Program. GM is the CEO of Hope For The Community (H4C).