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 |
| Secondary identifying numbers | Canadian Cancer Society 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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
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
Dr Christine Maheu
Scientific
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
| Study design | Multicentre prospective randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 measures | 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 therapists 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 patients 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). |
| Overall study start date | 01/10/2014 |
| Completion date | 01/10/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 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
McGill University
Montreal
H3A 2A7
Canada
H3A 2A7
Canada
Sponsor information
Canadian Cancer Society (Canada)
Charity
Charity
55 St Clair Avenue West
Suite 500
Toronto
M4V 2Y7
Canada
| Phone | +1 (0)416 323 7173 |
|---|---|
| research@cancer.ca | |
"ROR" |
https://ror.org/017343w90 |
Funders
Funder type
Charity
Canadian Cancer Society (Canada) - Quality of life grant # 702985
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Canadian Cancer Society – Ontario, Société canadienne du cancer, CCS, SCC
- Location
- Canada
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
Editorial Notes
27/04/2016: Publication reference added.
