Feasibility and Outcomes of Therapist-led Online Cancer Bereavement Groups

NCT07002424 | Active Not Recruiting DMC

• 1 other identifier: Project 0183
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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:

Conditions

Waitlist Control; Intervention (Training) Condition

Keywords

Online Bereavement Group; Cancer Loss; Therapist-Led

Outcome Measures

Primary Outcomes (7)

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

  is a 9-item self-report questionnaire that measures the severity of depressive symptoms. Kroenke et al. (2001) reported that the measure has strong psychometric properties: the internal consistency was 0.89 and test-retest reliability between patient self-report and mental health professional administering the measure telephonically 48 hours later was 0.84. The measure also has good convergent validity (r=0.73) with the mental health subscale of the Short- Form General Health Surv. The PHQ-9 has not been validated with bereaved populations.

  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)

  is a 7-item self-report questionnaire that measures the severity of anxiety symptoms. Spitzer et al., (2006) reported that the measure has strong psychometric properties: the internal consistency was 0.92 and test-retest reliability was 0.83 over a period of a week. The measure has strong convergent validity with the Beck Anxiety Inventory (r=0.72) and the anxiety sub-scale of the Symptom Checklist-90 (r=0.74). The GAD-7 has not been validated with bereaved populations.

  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)

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

  13-item self-report measure that examines three facets of prolonged grief disorder: feelings, thoughts and actions, occurring over the past month. The measure has strong psychometric properties. For example, Ashouri et al., (2024) found that this measure demonstrated good internal consistency (omega coefficient of 0.93), and test-retest reliability with an interval of 6 weeks being 0.89. The PG-13 was shown to be a reliable scale for the assessment of individuals at risk for developing PGD with high scores on internal consistency in bereaved Swedish parents (Pohlkamp et al., 2018). However, these properties have been validated with a few studies.

  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)

• PTSD Checklist for DSM-5

  is a 20-item self-report questionnaire that assesses symptoms of PTSD. Blevins et al., (2015) reported that the measure has strong psychometric properties: when tested with trauma-exposed undergraduate students, the internal consistency was 0.94 and the test-retest reliability was 0.82 over a period of a week. There appears to be no validation of the PCL-5 targeting traumatically bereaved individuals.

  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)

  is a post-session self - report questionnaire that asks about perceptions of key change processes in therapy. It is partly qualitative and captures perceptions of helpful and unhelpful aspects of the previous session. It is beyond the scope of this present study to analyse the qualitative data, however this measure provides valuable feedback, which the facilitators can be aware of and address if appropriate. Researchers will aim to foster trusting relationships to help the participants to feel engaged in the research process. Participants will be given opportunities to share their thoughts and reflections during the group to facilitate engagement with the content.

  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)

• The Self-Compassion Scale (SCS; Neff, 2003)

  is a 26-item self-report questionnaire that measures self-compassion. Raes et al. (2011) reported that the measure has strong psychometric properties: the internal consistency was 0.85 and the test-retest reliability over a period of five months was 0.71. The total score of the SCS-SF correlates highly (r=0.98) with the longer 26-item Self-Compassion Scale. Construct validity of the SCS-SF has not been tested but the long version of the SCS was negatively correlated (r=-0.65) with the self-criticism subscale of the Depressive Experiences Questionnaire. The SCS-SF has not been validated with bereaved populations.

  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)

• Oxford Grief-Social Disconnection Scale (OG-SD; Smith et al., 2020)

  is a 15-item scale developed from interviews with bereaved individuals. Smith et al., (2020) indicate that internal consistency for the total OG-SD and its subscales were good or excellent (Cronbach alpha 0.80). The OG-SD showed a good 7-day-retest reliability across the total and subscales, indicating a temporally stable assessment of perceived social disconnection (test-retest 0.94). However, although overall the OG-SD was deemed stable over time, other two subscales may be less stable over time. The test-retest sample was also relatively small, which means that it is possible that large effects may have been caused within a few individuals.

  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 (29)

• Demographic Information- Name

  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)

• Demographic Information- Address

  Baseline (1 week pre-group)

• Demographic Information - Age

  Baseline (1 week pre-group)

• Demographic Information- Gender

  Baseline (1 week pre-group)

• Demographic Information- Ethnicity

  Baseline (1 week pre-group)

Study Arms (2)

Immediate Treatment

EXPERIMENTAL

Participants randomised to non-waitlist, accessing the online bereavement group intervention immediately

Behavioral: Therapeutic - Psychological

Waitlist-Control Group

OTHER

participants randomised to waitlist-control accessing the online bereavement group intervention after a delay (three months later) immediate group

Behavioral: Therapeutic - Psychological

Interventions

Therapeutic - Psychological BEHAVIORAL

The intervention uses a transdiagnostic model that incorporates aspects of peer support, psychoeducation, trauma-informed cognitive behavioural therapy (CBT), Compassion focused therapy (CFT) models of distress. It also aligns itself to the Dual Processing Model of coping with bereavement (Stroebe \& Schut, 2010) and Tonkin's model of grief (Tonkin, 1996).

Immediate Treatment; Waitlist-Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University College, London: lead

Study Sites (1)

The Loss Foundation (Charity)

London, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 30983910 BACKGROUND

Study Officials

• Charlie Cole, Clinical Psychologist

  University College, London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 12, 2025
• First Posted: June 3, 2025
• Study Start: January 15, 2025
• Primary Completion: November 5, 2025
• Study Completion: December 15, 2025
• Last Updated: June 3, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)