A psychosocial group intervention to address fear of recurrence in women with cancer: a randomized controlled clinical trial
| ISRCTN | ISRCTN83539618 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN83539618 |
| Protocol serial number | Canadian Cancer Society grant # 702985 |
| Sponsor | Canadian Cancer Society (Canada) |
| Funder | Canadian Cancer Society (Canada) - Quality of life grant # 702985 |
- Submission date
- 31/07/2014
- Registration date
- 03/09/2014
- Last edited
- 27/04/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
The most frequently named unmet need in cancer survivors is fear of cancer recurrence (FCR). More than half of all cancer survivors will report moderate to high levels of FCR and is most often reported by women. Cancer survivors who experience recurrent thoughts that their cancer will come back tend to have higher distress levels, lower quality of life and have difficulty building future goals. The aim of the study is to reduce FCR, cancer distress, uncertainty level and improve quality of life.
Who can participate?
Women who have had a diagnosis of breast cancer or gynaecological cancer.
What does the study involve
Participants will be randomly allocated to receive one of two psychological group therapies. They receive psychological therapy for six weeks for 120 minutes each and will be put in a group of six to eight women with either breast cancer or gynecological cancer.
What are the possible benefits and risks of participating?
Benefits to participation include improved quality of life, reduction in the fear of cancer recurrence, cancer distress and learning new relaxation techniques. Possible risks include having difficulty facing your fear of cancer recurrence and not feeling relief from cancer distress or fear of cancer recurrence.
Where is the study run from?
Study is run at three sites.
1. The Princess Margaret Cancer Centre in the ELLICSR in Toronto, Ontario, Canada
2. The University of Ottawa in Ottawa, Ontario, Canada
3. Jewish General Hospital, Montreal, Quebec, Canada
When is the study starting and how long is it expected to run for?
The study will start in October 2014 and is expected to run for three years.
Who is funding the study?
Canadian Cancer Society (Canada)
Who is the main contact?
Dr Christine Maheu
christine.maheu@mcgill.ca
Contact information
Scientific
McGill University
Ingram School of Nursing
Wilson Hall, Room 401A
3506 University Street
Montreal
H3A 2A7
Canada
| Phone | +1 (0)514 616 5954 |
|---|---|
| christine.maheu@mcgill.ca |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre prospective randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Efficacy of a cognitive-existential (CE) group intervention to address fear of recurrence in women with cancer: a randomized controlled clinical trial |
| Study acronym | CE |
| Study objectives | Compared to a structurally equivalent control group, breast cancer or gynecological cancer survivors participating in the CE group intervention will: 1. Have lower levels of FCR 2. Show improvements in the following secondary outcomes: cancer-specific distress, quality of life, illness uncertainty, intolerance of uncertainty, perceived risk of cancer recurrence, and coping skills. We further postulate that group differences will be maintained over the six-month period following completion of the intervention. |
| Ethics approval(s) | Ethics Committees of: 1. McGill University - pending approval 2. University Health Network - pending approval 3. University of Ottawa - pending approval |
| Health condition(s) or problem(s) studied | Breast cancer and gynecological cancer |
| Intervention | 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. |
| Intervention type | Other |
| Primary outcome measure(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). |
| Key secondary outcome measure(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). |
| Completion date | 01/10/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target sample size at registration | 144 |
| Key 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. |
| Key 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. |
| Date of first enrolment | 01/10/2014 |
| Date of final enrolment | 01/10/2017 |
Locations
Countries of recruitment
- Canada
Study participating centre
H3A 2A7
Canada
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | feasibility study results | 01/09/2014 | Yes | No | |
| Protocol article | protocol | 25/04/2016 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
27/04/2016: Publication reference added.