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A Randomized Controlled Trial of Inquiry Based Stress Reduction (IBSR) Program for Cancer Survivors - Effects on Quality of Life, Psychological Measures,Physical Symptoms, and Biological Measurements.


Phase 2
18 Years
90 Years
Not Enrolling
Both
Cancer

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Trial Information

A Randomized Controlled Trial of Inquiry Based Stress Reduction (IBSR) Program for Cancer Survivors - Effects on Quality of Life, Psychological Measures,Physical Symptoms, and Biological Measurements.


Inclusion Criteria:



- Participants who were diagnosed with either:Breast cancer;Colorectal cancer;Prostate
cancer.

- 18 years and older;

- Awareness of their cancer diagnosis;

- Within three months to eighteen months after the completion of surgery, chemotherapy,
and/or radiotherapy.

- Able to read and complete questionnaires on their own.

Exclusion criteria:

- Participants not speaking Hebrew;

- Not able to give informed consent due to impaired mental or intellectual state

- Advanced cancer stage

- Current psychiatric diagnosis

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Quality of Life (QoL)

Outcome Description:

Validated 41 items questionnaire will be used to assess QoL, including: Measures of psychological status: Fear of recurrence, perceived stress, anxiety, and depressive symptoms. Physical symptoms: Fatigue, pain, sleep disturbance. Social concerns Spiritual well being

Outcome Time Frame:

All participants will be asked to fill the same questionnaires at the initiation of the study (T1) and again after 3 months (end of intervention)

Safety Issue:

No

Principal Investigator

Nadir Arber, Prof.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Tel Aviv Medical Center

Authority:

Israel: Ethics Commission

Study ID:

TASMC-13-NA-549-CTIL

NCT ID:

NCT01795404

Start Date:

June 2013

Completion Date:

December 2016

Related Keywords:

  • Cancer
  • IBSR
  • Cancer Survivors
  • Katie Byron
  • Quality of Life
  • Stress
  • Stress reduction

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