A psychosocial group intervention to address fear of recurrence in women with cancer: a randomized controlled clinical trial

• Register: ISRCTN
• Last refreshed on: 17 October 2016
• Main ID: ISRCTN83539618
• Date of registration: 03/09/2014
• Prospective Registration: Yes
• Primary sponsor: Canadian Cancer Society (Canada)
• Public title: A psychosocial group intervention to address fear of recurrence in women with cancer: a randomized controlled clinical trial
• Scientific title: Efficacy of a cognitive-existential (CE) group intervention to address fear of recurrence in women with cancer: a randomized controlled clinical trial
• Date of first enrolment: 01/10/2014
• Target sample size: 144
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN83539618
• Study type: Interventional
• Study design: Multicentre prospective randomized controlled trial (Quality of life)
• Phase: Not Applicable

Countries of recruitment

Canada

Contacts

• Name: Christine Maheu

Key inclusion & exclusion criteria

Inclusion criteria: 1. First diagnosis of BC or GC with stages I-III
2. Disease-free at the start of the group
3. 18 years or older
4. Completion of treatment, with the exception of adjuvant chemotherapy or hormonal replacement therapy
5. A score of 13 or greater on the severity subscale of the FCRI (range 0-36), suggesting clinical levels of FCR (7)
6. A score of at least 24 on the cancer-specific distress measure, indicating clinical levels of distress (Impact of Events Scale; range 0-75) (52, 53).
If a participant develops a recurrence in the course of the study, she will remain in the group but her follow-up data will be excluded from final analysis. Finally, all participants meeting inclusion criteria will take part in a baseline pre-group interview with the group leaders that will detail the general expectations of group work.
Exclusion criteria: 1. Non-English speakers
2. Previous cancer recurrence
3. Enrolled in another group psychotherapy at the time of the start of the study or during the course of the six sessions
4. Unresolved mental health disorder judged to be clinically contra-indicated and/or likely to affect the group work, based on disclosure by the potential participant or clinically identified by the group leader. These individuals will be offered individual mental health services.

Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

Breast cancer and gynecological cancer
Cancer

Intervention(s)

This study involved the comparison of two group intervention approaches to test the effectiveness at reducing fear of cancer recurrence. Upon meeting eligibility criteria that includes scoring a medium level of fear of cancer recurrence and cancer distress, women with breast or women with gynecological cancers will be randomized to either receive one of the two psychosocial group therapies. Each group will be comprised of either breast or gynecological cancer and will have six to eight women per group. Groups will be weekly for 6 weeks for 120 minutes each. All women who consent to participate will complete a questionnaire package before the start of the first session, at the end of the six sessions, at 3 and 6 months post-intervention.

Primary Outcome(s)

Fear of cancer recurrence will be measured using the Fear of Cancer Recurrence Inventory (FCRI) (Simard & Savard, 2009). The FCRI is a 42-item questionnaire that includes a global score as well as seven subscales including triggers, severity, psychological distress, functional impairment, insight, reassurance, and coping strategies. A score of 13 or greater on the nine-item severity subscale (range 0-36) indicates clinical level of FCR (54).

Secondary Outcome(s)

1. Cancer-specific distress with the Impact of Event Scale (IES) (Horowitz, Wilner, & Alvarez, 1979); The IES is a 15-item questionnaires that assesses cancer distress. It has two subscales, intrusive thoughts and avoidance, which provide a total score. Perceived risk of cancer recurrence will be assessed using a one-item question where respondents indicate their level of perceived personal risk for a cancer recurrence over the last two days (Bish et al., 2002).
2. Intolerance of uncertainty with be measured with the Intolerance of Uncertainty Scale (IUS) (Buhr & Dugas, 2002). The IUS is a 27-item four-factor questionnaire that represents uncertainty as stressful and upsetting, uncertainty as leading to the inability to act, uncertain events as being negative and to be avoided, and being uncertain as unfair (Buhr & Dugas, 2002).
3. Uncertainty in Illness will be measured by the Mishel Uncertainty in Illness Scale (MUIS-C) (Mishel, 1981). The MUIS-C consists of 23 items rated on a five-point Likert scale. Coping will be measured with the following three coping scales: (1) Cognitive Avoidance Questionnaire (Sexton & Dugas, 2008), that contains 25 items that measure avoidance coping; (2) the Reassurance-Seeking Behaviours subscale of the Health Anxiety Questionnaire (Lucock & Morley, 1996), that contains three items that pertain to body-checking and reassurance-seeking from loved ones; and 3) the Reassurance Questionnaire (Speckens, Spinhoven, Van Hemert, & Bolk, 2000), that contains 10 items that measure reassurance-seeking from physicians.
4. Quality of life will be measured with the SF-8 instrument (Ware, Kosinski, Dewey, & Gandek, 2001). The SF-8 is a health-related QoL measure that provides an assessment of general physical (PCS) and mental (MCS) health with a 4-week recall period..

Additional variables to control:
1. As group cohesion may influence the impact of our CE group intervention, we will measure this construct at the end of the 6-week intervention for both the intervention and the control group. Cohesion will be measured with the Group Cohesion Scale-Revised (GCS-R) (Treadwell, Laverture, Kumar, & Veeraraghavan, 2001). The GCS-R is a 25 item questionnaire measuring group cohesion in terms of interaction and communication among group members. An example of an item is 'group members usually feel free to share information'.
2. Group alliance: we will use the California Psychotherapy Alliance Scale (CALPAS) (Gaston, 1991). The CALPAS is a 24-item scale that has four theoretically derived alliance dimensions: (1) the 'therapeutic alliance'; (2) the 'working alliance'; (3) the therapist?s contribution to the alliance; (4) the agreement on goals and tasks of therapy.
3. Therapeutic working group alliance measurement will be taken immediately following the last session for both the intervention and the control group.
4. Satisfaction with therapy: will be measured using Satisfaction with Therapy and Therapist Scale Revised (STTS-R). The STTS-R is a 12-item scale measuring the patient?s level of satisfaction with both the group therapy and the therapist in the CBT group (Oei & Green, 2008).
5. Credibility of intervention will be measured using: Credibility Expectancy Questionnaire (CEQ) ? Version II, a scale for measuring treatment expectancy (six items) and rationale credibility (two items) (Devilly & Borkovec, 2000).

Secondary ID(s)

Canadian Cancer Society grant # 702985

Source(s) of Monetary Support

Canadian Cancer Society (Canada) - Quality of life grant # 702985