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NCT Number: NCT03270995

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • first diagnosis of BC or GC with stages between I-III;
  • disease-free at the start of the group;
  • women aged 18 years or older;
  • completion of treatment, with the exception of adjuvant chemotherapy or hormonal replacement therapy

Exclusion criteria

  • non-English speakers
  • previous cancer recurrence
  • enrolled in another group psychotherapy at the time of the start of the study or during the course of the 6 sessions
  • 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.

Treatment and study plan

Cognitive Existential Therapy Group 1

Behavioral

Six group sessions of two hour each using a cognitive-existential group approach

Supportive Therapy Group 2

Behavioral

Six group session of two hour each using a supportive group approach.

Primary outcomes

  1. Fear of cancer recurrence inventory

    Time frame: 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 outcomes

  1. Cancer-specific distress

    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

    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.

  2. Perceived risk of cancer recurrence

    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 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.

  3. Intolerance of uncertainty

    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 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.

  4. Uncertainty in Illness

    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 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.

Sponsors and collaborators

Lead sponsor

McGill University

Other

Collaborators

  • Canadian Cancer Society (CCS)
  • Princess Margaret Hospital, Canada
  • Sir Mortimer B. Davis - Jewish General Hospital
  • University of Ottawa

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
Sep 1, 2017
Registry last updated
Feb 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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