Active — Not RecruitingNot Applicable

Feasibility and Outcomes of Therapist-led Online Cancer Bereavement Groups

United Kingdom100 participantsStarted 2025-01-15

Plain-language summary

Background: The loss of loved one to cancer brings unique difficulties that impact on the bereavement experience. Mixed support exists for the effectiveness of in-person group interventions for bereaved caregivers, with barriers to accessing support including perceived stigmatisation and geographical constraints. Online bereavement interventions offer an accessible and effective means of providing grief support to various populations at the individual and group level. Research supports the effectiveness of online groups for those bereaved by cancer, although most of these studies are peer-led as opposed to therapist-led. Despite a growing rationale for the use of online groups for bereavement, there is little empirical evidence for therapist led groups, or for those bereaved by cancer. Objectives: This paper describes the protocol for a pilot feasibility trial evaluating the feasibility, potential effectiveness and acceptability of delivering online therapy groups for those bereaved by cancer. Methods and analysis: It will use a longitudinal pilot and feasibility methodology to evaluate a randomised controlled trial (RCT) design and its suitability for a future definitive RCT. Participants: A total of 100 adults who have lost a loved one to cancer will be randomised to receive the intervention immediately or after a delay three months later. Interventions: An eight-session online therapeutic group intervention led over 12 weeks based on models of cognitive behavioural therapy, compassion focused therapy and coping with bereavement. Primary outcome measures: Cancer- bereaved adults' grief intensity, depression, anxiety, PTSD, self-compassion and social disconnection. Acceptability of the intervention will also be measured including what participants found most helpful or unhelpful about the groups and any adverse outcomes. Data collection will occur at baseline, intervention completion and at follow up, 3 months after intervention completion. Results: The feasibility of trial procedures and the effect of the intervention on the outcomes will be tested,. Conclusions: At intervention completion, it is hoped that participants will show reductions across all outcomes measures with improvements remaining at follow up, compared to the waitlist-control group, warranting the need for a full-scale RCT to establish efficacy. Trial registration (intended registry): Protocol version: 1 (No amendments currently), Issued:

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. Adults at high risk to themselves or others in regard to suicide and/or self-harm
. Significant substance or alcohol misuse which would interfere with participants' ability to take part in the research
. Cannot be involved in other therapy at the same time elsewhere.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Mood Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer, & Williams, 2001)

Timeframe: Baseline (1 week pre-group) Session 1(Week 1) Session 2(week 2) Session 3(week 3) Session 4(week 4) Session 5(week 6) Session 6(week 8) Session 7(week 10) Session 8(week 12) Follow up (3 months post-group) WL: Additional follow up (3months post Baseline)

Generalized Anxiety Disorder-7 (GAD-7; Spitzer, Kroenke, Williams, & Löwe, 2006)

Prolonged Grief Disorder (PG - 13) (Prigerson et al., 2008)

PTSD Checklist for DSM-5

Timeframe: Baseline (1 week pre-group) Session 4(week 4) Session 8(week 12) Follow up (3 months post-group) WL: Additional follow up (3months post Baseline)

The Helpful Aspects of Therapy (HAT; Llewelyn, 1988)

Timeframe: Session 1 (Week 1) Session 2 (week 2) Session 3 (week 3) Session 4 (week 4) Session 5 (week 6) Session 6 (week 8) Session 7 (week 10) Session 8 (week 12)

Trial details

NCT IDNCT07002424

SponsorUniversity College, London

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-11-05

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