Managing Cancer And Living Meaningfully: study protocol for a randomized controlled trial (Toronto)

Trials | Full text 
 

Background

We have developed a novel and brief semi-structured psychotherapeutic intervention for patients with advanced or metastatic cancer, called Managing Cancer And Living Meaningfully. We describe here the methodology of a randomized controlled trial to test the efficacy of this treatment to alleviate distress and promote well-being in this population.

Inclusion/Exclusion Criteria

The inclusion criteria are: 1) ≥ 18 years of age; 2) fluency in English; 3) no cognitive impairment indicated in the medical record or by the attending oncologist; and 4) a confirmed diagnosis of stage III or IV lung cancer, any stage of pancreatic cancer (due to the aggressiveness of this disease), unresectable cholangiocarcinoma, unresectable liver cancer, unresectable ampullary or peri-ampullary cancer or other stage IV (metastatic) gastrointestinal cancer, stage III or IV ovarian and fallopian tube cancers, or other stage IV gynecological cancer; and stage IV breast, genitourinary, sarcoma, melanoma, or endocrine cancers (all of the above with expected survival of 12–18 months). Patients meeting inclusion criteria undergo a brief interview with a research staff member to identify the following exclusion criteria: 1) major communication difficulties; 2) inability to commit to the required 3–6 psychotherapy sessions (i.e., too ill to participate, lack of transportation, insufficient motivation due to lack of distress); 3) cognitive impairment as indicated by a score < 20 on the Short Orientation-Memory-Concentration (SOMC) test [31], unless deemed suitable at the recruiter’s discretion, or due to brain metastases; 4) actively receiving psychiatric or psychological intervention in the Department of Supportive Care (formerly the Department of Psychosocial Oncology and Palliative Care) at the Princess Margaret Cancer Centre at the time of study approach; 5) refusal to accept randomization; and 6) prior treatment with CALM therapy during an earlier phase of the study.....