Clinical trial NCT07002424: Feasibility and Outcomes of Therapist-led Online Cancer Bereavement Groups
Official title: A Protocol for a Pilot and Feasibility Randomised Controlled Trial of an Online Cancer Bereavement Group.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Waitlist Control
Intervention (Training) Condition
Keywords: Online Bereavement Group
Cancer Loss
Therapist-Led
Lead sponsor: University College, London
Sponsor class: OTHER
First posted: 2025-06-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: It will use a longitudinal pilot and feasibility methodology to evaluate a randomised controlled trial (RCT) design and its suitability for a further full-scale RCT. The study will include two parallel conditions: non-waitlist (online bereavement group), and a wait-list control condition.

Four groups are planned: Two whereby participants will be randomised to waitlist (WL) accessing the intervention after a delay and two with participants randomised to non-waitlist (non-WL), accessing the intervention immediately. Both groups will run simultaneously (twice a week, over 8 sessions covering a period of 12 weeks) but the WL groups will run parallel to the non-WL groups, three months later. Assessments will be conducted at baseline and post each session and post-intervention 3 months later.
Primary purpose: TREATMENT

Brief 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:

Detailed description: The loss of a loved one to cancer brings unique difficulties that impact the bereavement experience. Mixed evidence exists for the effectiveness of in-person group interventions for bereaved caregivers, with barriers to access including perceived stigmatisation and geographical constraints. Online bereavement interventions offer an accessible, destigmatising and effective means of providing grief support to various populations at the individual and group level. Research supports the effectiveness for 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 (if any) empirical evidence for therapist led groups, or for those bereaved by cancer.

A group bereavement therapy programme was developed by the Loss Foundation, a national cancer bereavement charity, who initiated the project. It will explore the impact of an eight-session therapeutic group intervention led over 12 weeks on cancer- bereaved adults' grief intensity, depression, anxiety, PTSD, self-compassion and social disconnection. Previous research within the Loss Foundation has demonstrated the effectiveness of an in-person cancer bereavement therapeutic group using a transdiagnostic model (Jerome et al., 2018). In this study, it was found that grief intensity and symptoms of posttraumatic stress disorder (PTSD), depression, and anxiety were reduced postintervention, and self-compassion increased. At follow-up, improvement remained for grief, PTSD, and depression. This intervention has been adapted and carried out several times from previous research, including methodological changes such as randomisation to a waitlist control and collection of weekly data. For example, previous research within The Loss Foundation explored the effectiveness of the in-person cancer bereavement therapeutic group compared to waitlist control with findings showing a reduction in grief intensity and increased self-compassion.

As this is the first online therapeutic bereavement group for those bereaved by cancer, this study offers a unique contribution to the literature, addressing a critical gap in the literature on evidence-based therapist led internet interventions for cancer bereaved adults. The intention is to ascertain the feasibility, acceptability and changes in self-report measures of the online version of the adapted group bereavement therapy programme for cancer. This feasibility pilot study will evaluate a randomised controlled trial (RCT) design to explore its suitability for a further full-scale RCT. Outcomes will be assessed by comparing intervention and wait-list control groups at baseline, post each session and postintervention 3 months later in terms of the following primary outcomes: grief intensity, depression, anxiety, PTSD, self-compassion and social disconnection.

Aims and objectives

1. The primary aim is to evaluate the feasibility and acceptability of delivering online bereavement group for cancer loss. This refers to feasibility to recruit, retain, randomise and acceptability as tracking participant satisfaction and any adverse outcomes.
2. The secondary aim is to explore the preliminary effectiveness by examining whether the online bereavement group intervention leads to improvements on various outcomes, compared to the waitlist control.

The investigators' hypotheses are informed by the results of previous research within The Loss Foundation, and previous literature suggesting that online groups may be similarly effective. In regard to the secondary aim of exploring preliminary effectiveness of the study, the investigators hypothesised that grief intensity and PTSD symptoms, depression, and anxiety will be reduced postintervention, and self-compassion will be increased, showing improvement from baseline, compared to the waitlist control. Further, the investigators hypothesise that at follow-up, improvement will be maintained for grief intensity, PTSD symptoms and depression.

Eligibility criteria: Inclusion Criteria:

* (1) Adults (aged 18 or over) who are bereaved by cancer, for example losing a partner, family member or friend
* (2) The time since death must have been more than 6 months, so as not to interfere with a natural recovery process (Henk Schut \& Stroebe, 2010)
* (3) Self-referral to The Loss Foundation or via a related organisation
* (4) Have the means to access the therapeutic group online
* (5) Participants consent to attending the intervention with the risk of a delay (e.g. by being randomised to the waitlist or non-waitlist group).

Exclusion Criteria:

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

Primary outcomes:
measure: 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)
measure: Generalized Anxiety Disorder-7 (GAD-7; Spitzer, Kroenke, Williams, & Löwe, 2006)
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)
measure: Prolonged Grief Disorder (PG - 13) (Prigerson et al., 2008)
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)
measure: 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)
measure: 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)
measure: The Self-Compassion Scale (SCS; Neff, 2003)
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)
measure: Oxford Grief-Social Disconnection Scale (OG-SD; Smith et al., 2020)
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)
Secondary outcomes:
measure: Demographic Information- Name
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)
measure: Demographic Information- Address
timeFrame: Baseline (1 week pre-group)
measure: Demographic Information - Age
timeFrame: Baseline (1 week pre-group)
measure: Demographic Information- Gender
timeFrame: Baseline (1 week pre-group)
measure: Demographic Information- Ethnicity
timeFrame: Baseline (1 week pre-group)
measure: Demographic Information- Marital status
timeFrame: Baseline (1 week pre-group)
measure: Demographic Information- Highest level qualification
timeFrame: Baseline (1 week pre-group)
measure: Demographic Information- Employment
timeFrame: Baseline (1 week pre-group)
measure: Demographic Information- Psychological treatment since bereavement
timeFrame: Baseline (1 week pre-group)
measure: Demographic Information - Gender of deceased
timeFrame: Baseline (1 week pre-group)
measure: Bereavement characteristics: Length of relationship with deceased
timeFrame: Baseline (1 week pre-group)
measure: Bereavement characteristics -Time since death
timeFrame: Baseline (1 week pre-group)
measure: Bereavement characteristics - Relationship with deceased
timeFrame: Baseline (1 week pre-group)
measure: Bereavement characteristics - Co-habiting with deceased prior to death
timeFrame: Baseline (1 week pre-group)
measure: Bereavement characteristics - Contact with deceased prior to death
timeFrame: Baseline (1 week pre-group)
measure: - Bereavement characteristics Frequency of seeing deceased in 3 months preceding death
timeFrame: Baseline (1 week pre-group)
measure: Bereavement characteristics Present at the death,
timeFrame: Baseline (1 week pre-group)
measure: Bereavement characteristics - death of other loved ones in past 3 years.
timeFrame: Baseline (1 week pre-group)
measure: Recruitment and uptake-Source of referral to the study
timeFrame: Baseline (1 week pre-group)
measure: Recruitment and uptake- number consenting to participate
timeFrame: Baseline (1 week pre-group)
measure: Recruitment and uptake- those eligible/willing to be randomised.
timeFrame: Baseline (1 week pre-group)
measure: Adherence and attrition- A record of participation completion of outcome measurements
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)
measure: Adherence and attrition- Attendance
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)
measure: Acceptability - Intervention
timeFrame: Session 8(week 12- 1 week post-group), Follow up 2 (3 months post-group).
measure: Acceptability- Adverse cirumstances
timeFrame: Session 8(week 12- 1 week post-group), Follow up 2 (3 months post-group).
measure: Acceptability- Intervention Content
timeFrame: Session 8(week 12- 1 week post-group), Follow up 2 (3 months post-group).
measure: Acceptability- Online modality
timeFrame: Session 8(week 12- 1 week post-group), Follow up 2 (3 months post-group).
measure: Acceptability- Facilitator effectiveness
timeFrame: Session 8(week 12- 1 week post-group), Follow up 2 (3 months post-group).
measure: Acceptability- Group size
timeFrame: Session 8(week 12- 1 week post-group), Follow up 2 (3 months post-group).
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: The Loss Foundation (Charity)
Study officials:
affiliation: University College, London
name: Charlie Cole, Clinical Psychologist
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jerome H, Smith KV, Shaw EJ, Szydlowski S, Barker C, Pistrang N, Thompson EH. Effectiveness of a Cancer Bereavement Therapeutic Group. J Loss Trauma. 2019 Jan 7;23(7):574-587. doi: 10.1080/15325024.2018.1518772.