Feasibility and Impact of Group Interventions on Breast Cancer Patients Well-being

NCT02569294 | Completed

• 1 other identifier: Y-HYP-CBT-037
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

This is a clinical non-randomized prospective study. This study had two objectives. The fist one was to determine the interest of breast cancer patients in participating in one of three group interventions (CBT, yoga or self-hypnosis) by assessing the participation rate, the reasons for choosing a particular group or decline the offer. The second objective was to evaluate and compare the benefits of these three interventions on emotional distress, QoL, sleep quality and mental adjustment to cancer, at three times after the end of the interventions (just after the end, at a 3-month and at a 9-month follow-up).

Conditions

Breast Cancer

Keywords

group interventions; emotional distress; breast cancer; yoga; hypnosis; cognitive-behavioral therapy

Outcome Measures

Primary Outcomes (3)

• Interest of patients in the three groups

  The first outcome is to determine the interest of breast cancer patients in participating in one of three group interventions (CBT, yoga or self-hypnosis) by assessing the participation rate in each group (N and %).

  3 years

• Reasons for choosing a particular group

  The second outcome is to determine the reasons for choosing a particular group (open question).

  3 years

• Reasons for declining to participate

  The third outcome is to determine the reasons for declining to participate to the groups (open question).

  3 years

Secondary Outcomes (4)

• Emotional distress

  4 years

• Quality of Life

  4 years

• Mental adjustment to cancer

  4 years

• Quality of sleep

  4 years

Study Arms (4)

Choice 1: Yoga intervention

EXPERIMENTAL

See intervention description

Behavioral: Yoga intervention

Choice 2: Hypnosis intervention

EXPERIMENTAL

See intervention description

Behavioral: Hypnosis intervention

Choice 3: CBT intervention

EXPERIMENTAL

See intervention description

Behavioral: CBT intervention

Control group

NO INTERVENTION

Participants who agreed not to participate in any of the interventions proposed.

Interventions

Yoga intervention BEHAVIORAL

Hatha-yoga intervention included 6 weekly 90-min sessions in groups of 3 to 8 participants led by Hatha-yoga trained teachers. This program was developed previously in Montreal and the following were included at each session: 1) preparatory warm-up synchronized with breathing; 2) selected postures (e.g. forward , backward-, and side-bending asanas in sitting and lying positions); 3) deep relaxation; 4) alternate-nostril breathing or pranayama; and 5) meditation. Each participant received a DVD to encourage at-home practice.

Choice 1: Yoga intervention

Hypnosis intervention BEHAVIORAL

Hypnosis intervention included 6 sessions of 2 hours every 2 weeks. This was led by an anesthesist with experience in oncology and trained in hypnosis. Based on years of consultation with cancer patients, her team created a negotiating approach that fosters shared decision-making through using tasks that are centered on general well-being rather than on the health problem itself. Patients were asked to be actively involved. Several topics are addressed through tasks: eg. adjusting self-expectations. Patients were also required to keep a work-diary that was reviewed at the beginning of each session. At the end of the session, a 15-min hypnosis exercise is conducted. They receive CDs containing the hypnosis exercises and homework assignments.

Choice 2: Hypnosis intervention

CBT intervention BEHAVIORAL

CBT intervention included 6 weekly 90-min sessions in groups of 3 to 8 participants led by CBT-trained psychologists with experience in psycho-oncology. This program was developed by team leaders and is modelled on the work of Andersen et al. (2008) and Savard (2010). The intervention targets were: 1) breast cancer, meaning of illness, understanding stress and responses to it; 2) impact of treatment on body image; 3) impact of treatment on self-esteem; 4) fear of recurrence; 5) relationships with relatives and health professionals; and 6) life projects, return to daily activities and work. Relaxation training took place at the end of each session and participants performed tasks between sessions.

Choice 3: CBT intervention

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• first breast cancer without metastases
• between 18 and 75-year-old
• ability to read, write and speak French.

You may not qualify if:

• Patients with a diagnosed psychiatric disorder or dementia

Sponsors & Collaborators

• University of Liege: lead

Study Sites (1)

University Hospital of Liege

Liège, B-4000, Belgium

Location

Related Publications (1)

• Gregoire C, Nicolas H, Bragard I, Delevallez F, Merckaert I, Razavi D, Waltregny D, Faymonville ME, Vanhaudenhuyse A. Efficacy of a hypnosis-based intervention to improve well-being during cancer: a comparison between prostate and breast cancer patients. BMC Cancer. 2018 Jun 22;18(1):677. doi: 10.1186/s12885-018-4607-z.

  PMID: 29929493 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Guy Jerusalem, Prof.

  University of Liege

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D.

Study Record Dates

• First Submitted: October 2, 2015
• First Posted: October 6, 2015
• Study Start: January 1, 2013
• Primary Completion: March 1, 2016
• Study Completion: June 1, 2016
• Last Updated: July 14, 2017

Record last verified: 2017-07

Locations

BE (1)