Protocol No.UW26053
Principal InvestigatorCostanzo, Erin
PhaseN/A
Age GroupAdult
Management Group(s) Palliative Care

Title
Iterative Adaptation of a Biobehavioral Intervention for Patients with Advanced Cancers

Description
Aim 1: Develop and refine an alpha version of a ReSET intervention treatment manual. We will use a mixed-methods, modified Delphi approach to elicit and integrate iterative feedback from a diverse panel of professional colleagues with clinical expertise in palliative care medicine, biobehavioral oncology, and intervention science. This procedure will occur within the study team and collaborations with research and clinical experts outside of the study team. However, this aim will not include the input from any patients/patient participants. We anticipate that this process will take 1 - 3 months.

Aim 2: Engage stakeholders to assess feasibility and acceptability of the ReSET intervention within the palliative care setting by conducting focus groups and/or individual interviews with palliative care clinicians and patients with advanced cancers. Using the revised version of the ReSET intervention treatment manual, we will meet with 12 patients with advanced cancers via focus group (two groups of six people). Focus groups will last 60 - 90 minutes. We will describe the ReSET intervention and provide them with the intervention manual to review. We will invite patient participants to describe their own experiences with symptoms of fatigue, insomnia, and depression, as well as provide feedback regarding the feasibility and acceptability of the alpha ReSET intervention and intervention treatment manual, with particular attention to content and intervention delivery. These results will be analyzed using rapid qualitative analysis and shared with the panel of experts from Aim 1. Using the alpha version of the ReSET intervention treatment manual, we will meet with 6 members of the UW Carbone Cancer Center’s Palliative Care Team and/or Palliative and Supportive Care DOT. We will meet with these members via individual interviews. Interviews are anticipated to last between 30 - 60 minutes.We will describe the ReSET intervention and provide them with the intervention manual to review. We will ask participants to describe their experiences of managing symptoms of fatigue, insomnia, and depression among patients with advanced cancers being seen in Palliative Care, as well as provide feedback regarding the feasibility and acceptability of the alpha ReSET intervention and intervention treatment manual in the context of the palliative care setting, with particular attention to content, patient eligibility, and intervention delivery. These results will be analyzed using rapid qualitative analysis and shared with the panel of experts from Aim 1.

As part of this study’s Aim2, we plan to identify and interview 6 members of the UW Carbone Cancer Center’s Palliative Care Team. These providers may or may not be active members of the Palliative and Supportive Care DOT. Regardless of their status within the DOT, all providers will be consented prior to their participation in the study’s individual interviews. We will also ask that any conversations that occur within the interviews not be discussed outside of that setting to protect participant confidentiality.

Objective
To develop and refine an alpha version of a ReSET intervention treatment manual using a mixed-methods, modified Delphi approach to elicit and integrate iterative feedback from a diverse panel of professional colleagues with clinical expertise in palliative care medicine, biobehavioral oncology, and intervention science as well as palliative care patient advocates recruited from UW Carbone Cancer Center.

Treatment Iterative Adaptation of a Biobehavioral Intervention for Patients with Advanced Cancers

Key Eligibility Inclusion criteria for Aim 1 of this study is not applicable.

Aim2: Inclusion criteria for focus group of patients with advances cancers (n=12):
1. Adult; ages 18+
2. Fluent in English (reading, writing, speaking)
3. Treated at UW Carbone Cancer Center
4. Diagnosed with cancer (any type)
5. Diagnosed with an advanced stage of cancer (i.e., Stages 3 and 4)

Inclusion criteria for individual interviews of members of the UW Carbone Cancer Center Palliative and Supportive Care team or DOT team (up to 6 members of the palliative care DOT:
1. Adult; ages 18+
2. Fluent in English (reading, writing, speaking)
3. Employed at UW Carbone Cancer Center
4. Current member of UW Health's Palliative Care Team (physician, NP, PA, RN, Chaplain, Psychologist, Social Worker)

Applicable Disease Sites
Anal; Any Site; Bladder; Brain/Central Nervous System; Breast; Cervix; Colon and Rectum; Endocrine cancers; Esophagus; Gastrointestinal cancers, other; Genitourinary cancers, other; Head and Neck; Hematologic cancers, other; Ill-Defined Sites; Kidney; Leukemia; Liver; Lung; Lymphoma; Melanoma/Skin cancer; Multiple Myeloma; Ovary; Pancreas; Prostate; Sarcoma; Stomach; Thyroid; Unknown Sites; Uterus

Participating Institutions
UW Health Eastpark Medical Center; UW Health University Hospital