A Pilot Randomized Controlled Trial of Families Addressing Cancer Together for Parents With Cancer: Feasibility, Acceptability, and Preliminary Effects
Corresponding Author
Zev M. Nakamura
Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA
Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA
Correspondence: Zev M. Nakamura
Search for more papers by this authorAllison M. Deal
Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA
Search for more papers by this authorJustin M. Yopp
Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA
Search for more papers by this authorAlexis C. Wardell
Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA
Search for more papers by this authorMichelle Manning
Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA
Search for more papers by this authorPhoebe Pak
Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA
Search for more papers by this authorAnna Cassidy
Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA
Search for more papers by this authorLaura C. Hanson
Division of Geriatric Medicine & Palliative Care and Hospice Program, University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA
Search for more papers by this authorAhrang Jung
School of Nursing, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA
School of Nursing, University of North Carolina at Greensboro, Greensboro, North Carolina, USA
Search for more papers by this authorMi-Kyung Song
Center for Nursing Excellence in Palliative Care, Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, Georgia, USA
Search for more papers by this authorCarmina G. Valle
Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA
Department of Nutrition, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA
Search for more papers by this authorCole Walker
University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA
Search for more papers by this authorHannah Won
Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA
Search for more papers by this authorEliza M. Park
Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA
Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA
Department of Medicine, Division of Oncology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA
Search for more papers by this authorDonald L. Rosenstein
Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA
Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA
Department of Medicine, Division of Oncology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA
Search for more papers by this authorCorresponding Author
Zev M. Nakamura
Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA
Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA
Correspondence: Zev M. Nakamura
Search for more papers by this authorAllison M. Deal
Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA
Search for more papers by this authorJustin M. Yopp
Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA
Search for more papers by this authorAlexis C. Wardell
Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA
Search for more papers by this authorMichelle Manning
Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA
Search for more papers by this authorPhoebe Pak
Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA
Search for more papers by this authorAnna Cassidy
Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA
Search for more papers by this authorLaura C. Hanson
Division of Geriatric Medicine & Palliative Care and Hospice Program, University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA
Search for more papers by this authorAhrang Jung
School of Nursing, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA
School of Nursing, University of North Carolina at Greensboro, Greensboro, North Carolina, USA
Search for more papers by this authorMi-Kyung Song
Center for Nursing Excellence in Palliative Care, Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, Georgia, USA
Search for more papers by this authorCarmina G. Valle
Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA
Department of Nutrition, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA
Search for more papers by this authorCole Walker
University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA
Search for more papers by this authorHannah Won
Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA
Search for more papers by this authorEliza M. Park
Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA
Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA
Department of Medicine, Division of Oncology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA
Search for more papers by this authorDonald L. Rosenstein
Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA
Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA
Department of Medicine, Division of Oncology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA
Search for more papers by this authorFunding: The project was supported by the National Institutes of Health (NIH) through Grant Award 5K07CA218167 (Eliza M. Park) and the Foundation of Hope (Eliza M. Park).
Eliza M. Park and Donald L. Rosenstein co-senior authorship.
ABSTRACT
Objective
To evaluate the feasibility, acceptability, and preliminary efficacy of Families Addressing Cancer Together (FACT), a web-based, individually tailored, psychoeducational intervention for parents with cancer to improve illness-related communication with their minor children.
Methods
Parents with stage I-IV solid tumors who had children ages 3–17 were randomized to 6 weeks of FACT versus waitlist control. Feasibility was assessed by rates of recruitment and retention. Acceptability (primary outcome) was defined a priori as ≥ 75% of FACT participants rating FACT ≥ 12 (on an 18-point study-specific scale), and semi-structured interviews provided additional qualitative acceptability information. Generalized estimating equation methods were used to assess preliminary efficacy for communication self-efficacy, depression, and anxiety; Fisher's exact tests explored differences in individual communication beliefs and behaviors.
Results
Forty-eight approached patients enrolled (recruitment rate: 73%), 85% were retained through the post-intervention assessment, and 78% rated FACT as acceptable. In the FACT group compared to control, the modeled improvement in CSES scores from baseline to post-intervention was 9.5 versus 0 points (p = 0.004). FACT participants were more likely to have told their children that they have cancer (83.3% vs. 52.2%, p = 0.03) and felt more prepared to answer their children's questions about cancer (p = 0.02). Groups did not differ in depression or anxiety.
Conclusions
FACT was feasible, acceptable, and demonstrated potential to improve parents' communication self-efficacy, beliefs, and behaviors. A large scale randomized controlled trial of FACT is needed to confirm these benefits and evaluate longer-term effects on psychological outcomes for parents with cancer and their children.
Conflicts of Interest
The authors declare no conflicts of interest.
Open Research
Data Availability Statement
The protocol is available at clinicaltrials.gov. Data that support the findings of this study are available from the corresponding author upon reasonable request.
Supporting Information
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Please note: The publisher is not responsible for the content or functionality of any supporting information supplied by the authors. Any queries (other than missing content) should be directed to the corresponding author for the article.
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