Doris Dickerson Coward | Search PubMed

PubMed2002

Partial randomization design in a support group intervention study.

Randomized clinical trial (RCT) designs, in which participants are randomly assigned to treatment and control groups, are considered the gold standard of experimental design. However, if potential participants have a strong preference for a particular study group and/or when participatory effort must be sustained over a lengthy study time frame, they may deem randomization unacceptable, refuse to be in the study, and hence prevent the purpose of randomization from being realized. This article describes several alternative designs and the decision-making process prior to selecting a partially randomized preference trial (PRPT) design to accommodate preferences of women with breast cancer for participation in a support group intervention pilot study. Recruiting women into the two randomized arms of the PRPT was problematic because most potential participants expressed a preference for a particular study group. Possible reasons for failure to randomize more of the potential participants are discussed and suggestions for future research proposed.

Breast Neoplasms↗

PubMedDate not supplied

Facilitation of self-transcendence in a breast cancer support group: II.

PURPOSE/OBJECTIVES: To pilot a second support group intervention study promoting self-transcendence perspectives and activities and to document changes over time in well-being in support group participants compared with nonparticipants. DESIGN: Quasiexperimental, partial randomization, preference trial design. SETTING: An urban breast cancer resource center established by survivors. SAMPLE: 41 women with newly diagnosed breast cancer were recruited, and 39 completed the study. 22 women participated in three intervention support groups; 17 were in a comparison group. METHODS: The intervention was an eight-week, closed support group based on self-transcendence theory. Data were collected three times during 14 months. MAIN RESEARCH VARIABLES: Support group intervention, self-transcendence, and emotional and physical well-being. FINDINGS: The intervention group had lower scores than the comparison group on self-transcendence and well-being variables at baseline (time [T] 1). Scores were higher for both groups postintervention (T2), with no differences between groups. One year postintervention (T3), intervention group scores again were lower than comparison group scores. Intervention group T3 scores were unchanged from T2. CONCLUSIONS: Most potential participants were unwilling to risk being randomized into a nonpreferred group. Activities based on self-transcendence theory were associated with expanded perspectives and activities and an improved sense of well-being in support group participants at the end of the intervention, but not one year later. Findings from the pilot studies informed a study currently in progress. IMPLICATIONS FOR NURSING: Nurses should maintain awareness of local resources for support and make that information available to women when they are newly diagnosed with breast cancer, during their treatment, and later.

Adaptation, Psychological↗