Breast Neoplasms, Endometrial Neoplasms, Ovarian Neoplasms, Uterine Cervical Neoplasms
Conditions
Keywords
breast cancer, gynecological cancer, fear of cancer recurrence, clinical trial, randomized controlled trial, group therapy, intervention, cognitive-existential
Brief summary
Studies show that cancer survivors have unmet needs, the most frequently cited being fear of recurrence (FCR). Moderate to high levels of FCR have been reported by as much as 49% of cancer patients and are more prevalent among women. FCR is associated with psychological distress, lower quality of life, and increased health care utilization. Little evidence exists that these problems are being addressed by current medical management.
Detailed description
The present study aims to further test this cognitive-existential group intervention for FCR in a randomized control clinical trial with women with breast or gynecological cancer. Participants will be recruited from Princess Margaret Hospital, Mount Sinai Hospital, the Jewish General Hospital, and the Ottawa Hospital. 144 cancer patients will be randomized to either receive the 6 week cognitive-existential group intervention or to a control group. The control group will also consist of six weekly sessions during which participants will discuss the challenges of living with a cancer diagnosis, but without a clear focus on FCR. Women randomized to participate in the study will a) be 18 years or older; b) have a first diagnosis of breast or gynecological cancer with stages between IIII; c) be disease free at the start of the group; d) gave clinical levels of fear of cancer recurrence; e) have clinical levels of distress; and f) have completed their cancer treatment.
Interventions
BEHAVIORALCognitive Existential Therapy Group 1
Six group sessions of two hour each using a cognitive-existential group approach
BEHAVIORALSupportive Therapy Group 2
Six group session of two hour each using a supportive group approach.
Sponsors
Canadian Cancer Society (CCS)
Princess Margaret Hospital, Canada
University of Ottawa
Sir Mortimer B. Davis - Jewish General Hospital
McGill University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. first diagnosis of BC or GC with stages between I-III; 2. disease-free at the start of the group; 3. women aged 18 years or older; 4. completion of treatment, with the exception of adjuvant chemotherapy or hormonal replacement therapy
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 6 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fear of cancer recurrence inventory | up to 12 months post-intervention follow-up | Fear of cancer recurrence will be measured using the Fear of Cancer Recurrence Inventory (FCRI). The FCRI is a 42-item questionnaire that includes a global score as well as seven sub-scales 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 \[55\]. The instrument has been shown to have adequate reliability and validity (construct validity; r=0.68 to 0.77; and reliability scores; α=0.95). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cancer-specific distress | Pre- two weeks prior to the intervention, Post-one week after the end of the intervention, and three (T3) and six months (T4) following the end of the intervention | Cancer-specific distress with the Impact of Event Scale (IES)\]; The IES is a 15 items questionnaires that assesses cancer distress. It has two sub-scales, intrusive thoughts and avoidance, which provide a total score. |
| Perceived risk of cancer recurrence | Pre- two weeks prior to the intervention, Post-one week after the end of the intervention, and three (T3) and six months (T4) following the end of the intervention | 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. |
| Intolerance of uncertainty | Pre- two weeks prior to the intervention, Post-one week after the end of the intervention, and three (T3) and six months (T4) following the end of the intervention | Intolerance of uncertainty with be measured with the Intolerance of Uncertainty Scale (IUS) \[58\]. 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. |
| Uncertainty in Illness | Pre- two weeks prior to the intervention, Post-one week after the end of the intervention, and three (T3) and six months (T4) following the end of the intervention | Uncertainty in Illness will be measured by the Mishel Uncertainty in Illness Scale (MUIS-C) \[59\]. The MUIS-C consists of 23 items rated on a five-point Likert scale. |
Countries
Canada
Outcome results
None listed