Cognitive-Existential Group Therapy to Reduce Fear of Cancer Recurrence: A RCT Study

NCT03270995CompletedNAINTERVENTIONAL

Summary

Key Facts

Lead Sponsor

McGill University

Enrollment

144

Start Date

2014-10-01

Completion Date

2020-02-01

Study Type

INTERVENTIONAL

Official Title

Efficacy of a Cognitive-existential Intervention to Address Fear of Recurrence in Women With Cancer: a Randomized Controlled Clinical Trial

Interventions

Cognitive Existential Therapy Group 1Supportive Therapy Group 2

Conditions

Breast NeoplasmsOvarian NeoplasmsEndometrial NeoplasmsUterine Cervical Neoplasms

Eligibility

Age Range

18 Years+

Sex

FEMALE

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.

Outcome Measures

Primary Outcomes

Fear of cancer recurrence inventory

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).

Time frame: up to 12 months post-intervention follow-up

Secondary Outcomes

Cancer-specific distress

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.

Time frame: 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

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.

Time frame: 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

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.

Time frame: 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

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.

Time frame: 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

Locations

The Ottawa Hospital, Ottawa, Canada

Princess Margaret Hospital, Toronto, Canada

Jewish General Hospital, Montreal, Canada

Cognitive-Existential Group Therapy to Reduce Fear of Cancer Recurrence: A RCT Study