Dataset Information

Study protocol for the Exercising Together© trial: a randomized, controlled trial of partnered exercise for couples coping with cancer.

ABSTRACT:

Background

Most cancer survivors are married, and cancer strains the physical and mental health of each partner and their intimate relationship. We created a partnered strength training program, Exercising Together©, where the survivor and his/her partner exercise as a team in order to improve physical and mental health of both members of the couple as well as the quality of their relationship. We have not yet determined if Exercising Together© is similarly effective in couples coping with different types of cancer nor if training as a team has unique and added benefits over those derived from supervised group training and/or shared behavior change. The purpose of this study is to determine the unique benefits of Exercising Together© on physical, mental, and relational health in couples coping with breast, prostate, or colorectal cancer.

Methods

Survivors of prostate, breast and colorectal cancer (N = 294, 98 per cancer site) and their intimate, co-residing partners are recruited to participate in a single-blind, parallel group, randomized trial comparing three exercise groups that train twice per week for 6 months. Couples are randomized to one of three groups: (1) Exercising Together© where partners train as a team in a supervised group setting; (2) separate supervised group exercise classes for survivors or partners, respectively; (3) unsupervised home exercise program provided to each partner. The primary outcome is relationship quality (dyadic coping by the Dyadic Coping scale, emotional intimacy by the Dyadic Adjustment Scale, physical intimacy by the Physical Intimacy Behavior Scale, and symptom incongruence). Secondary outcomes are physical health (% body fat by DXA, serum fasting lipids (triglycerides, HDL, and LDL cholesterol), insulin resistance (HOMA-IR), resting blood pressure, C-reactive protein, TNF alpha, and physical functioning by the short Physical Performance Battery and SF-36) and mental health (depressive symptoms, anxiety, fear of recurrence) of each partner. Outcomes are collected at baseline, mid (3 months), post-intervention (6 months), and follow-up (12 months).

Discussion

Exercising Together© could shift the paradigm of survivorship care toward novel couple-based approaches that could optimize outcomes for each partner because their health is interdependent on each other and their relationship.

Trial registration

ClinicalTrials.gov NCT03630354 . Registered August 14, 2018.

SUBMITTER: Winters-Stone KM

PROVIDER: S-EPMC8404361 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:BackgroundLevels of physical activity (PA) in UK children are much lower than recommended and novel approaches to its promotion are needed. The Children, Parents and Pets Exercising Together (CPET) study is the first exploratory randomised controlled trial (RCT) to develop and evaluate an intervention aimed at dog-based PA promotion in families. CPET aimed to assess the feasibility, acceptability and potential efficacy of a theory-driven, family-based, dog walking intervention for 9-11 year olds.MethodsTwenty-eight families were allocated randomly to either receive a 10-week dog based PA intervention or to a control group. Families in the intervention group were motivated and supported to increase the frequency, intensity and duration of dog walking using a number of behaviour change techniques. Parents in the intervention group were asked to complete a short study exit questionnaire. In addition, focus groups with parents and children in the intervention group, and with key stakeholders were undertaken. The primary outcome measure was 10 week change in total volume of PA using the mean accelerometer count per minute (cpm). Intervention and control groups were compared using analysis of covariance. Analysis was performed on an intention to treat basis.ResultsTwenty five families were retained at follow up (89%) and 97% of all outcome data were collected at baseline and follow up. Thirteen of 14 (93%) intervention group parents available at follow up completed the study exit questionnaire and noted that study outcome measures were acceptable. There was a mean difference in child total volume of PA of 27 cpm (95% CI -70, 123) and -3 cpm (95% CI -60, 54) for intervention and control group children, respectively. This was not statistically significant. Approximately 21% of dog walking time for parents and 39% of dog walking time for children was moderate-vigorous PA.ConclusionsThe acceptability of the CPET intervention and outcome measures was high. Using pet dogs as the agent of lifestyle change in PA interventions in children and their parents is both feasible and acceptable, but did not result in a significant increase in child PA in this exploratory trial.Trial registrationISRCTN85939423.

Project description:IntroductionProstate cancer can negatively impact the health of patients and their spouse, particularly early on in the cancer trajectory.PurposeTo determine the feasibility and acceptability of dyadic exercises during radiation therapy and preliminary efficacy on physical, mental, and relational outcomes for men and their spouses. Exercising Together©, originally designed as a 6-month dyadic resistance training program for couples post-treatment, was adapted for the radiation setting.MethodsWe conducted a single-group pilot feasibility study of Exercising Together© in men scheduled for radiation therapy for prostate cancer and their spouse. Couples attended supervised exercise sessions thrice weekly throughout radiation treatment and were followed up 8 weeks later. Primary outcomes were feasibility and acceptability with secondary outcomes of changes in physical (physical functioning (short physical performance battery (sPPB)), gait speed (m/s), functional capacity (400-m walk (min), physical activity (min/week)), mental (depressive symptoms (CES-D), and anxiety (SCL-90 ANX)), and relationship (Dyadic Coping, Role Overload, and Physical Intimacy Behavior Scales) health outcomes for each partner. Participants completed an evaluation post-intervention.ResultsTen couples enrolled and 8 completed the intervention, attending 83% of scheduled sessions. Couple satisfaction with the intervention was high (patients: mean difference (MD) = 9.4 ± 1.9 and spouses: MD = 10.0 ± 0.0, on a 1-10 scale). At post-intervention, gait speed (MD = 0.1; 95%CI: 0.1, 0.2; p = 0.003; d = 0.94) and functional capacity (MD = -0.6; 95%CI: -0.9, 0.3; p = 0.002; d = -0.42) improved in patients and sPPB in spouses (MD = 1.3; 95%CI: 0.3, 2.2; p = 0.02; d = 0.71). Total physical activity increased non-significantly for patients and significantly for spouses at post-intervention and decreased at follow-up (MD = 179.6; 95%CI: 55.4, 303.7; p = 0.01; d = 1.35 and MD = -139.9; 95%CI: -266.5, 13.3; p = 0.03; d=1.06). Among patients, anxiety and active engagement significantly improved post-intervention (MD = -2.3; 95%CI: -3.8, 0.7; p = 0.01; d = -0.43 and MD = 2.5; 95%CI: 0.7, 4.3; p = 0.01; d = 0.98, respectively). There were modest effects on other physical, mental, and relationship health domains in patients and spouses.ConclusionA modified version of Exercising Together© is a feasible and acceptable program during radiation therapy for prostate cancer and shows preliminary evidence for improvements on physical, mental, and relational health in both patient and spouse. A larger, fully powered randomized controlled trial is warranted and could help shift the landscape toward dyadically targeted interventions.Trial registrationThis study was registered on ClinicalTrials.gov on February 18th, 2018 ( NCT03418025 ).

Project description:Almost 50% of Americans have elevated low-density lipoprotein cholesterol (LDL-C). The behaviors required to lower LDL-C levels may be difficult to adhere to if they are inconsistent with spouses' health practices, and, alternatively, may be enhanced by enlisting support from the spouse. This trial extends previous trials by requiring spouse enrollment, teaching spouses how to provide emotional and instrumental support, allowing patients to decide which component of the intervention they would like to receive, and having patients determine their own goals and action plans.Veteran outpatients with above-goal LDL-C (N = 250) and their spouses are randomized, as a couple, to receive printed education materials only or the materials plus an 11-month, nurse-delivered, telephone-based intervention. The intervention contains four modules: medication adherence, diet, exercise, and patient-physician communication. Patients decide which modules they complete and in which order; modules may be repeated or omitted. Telephone calls are to patients and spouses separately and occur monthly. During each patient telephone call, patients' progress is reviewed, and patients create goals and action plans for the upcoming month. During spouse telephone calls, which occur within one week of patient calls, spouses are informed of patients' goals and action plans and devise strategies to increase emotional and instrumental support.The primary outcome is patients' LDL-C, measured at baseline, 6 months, and 11 months. Linear mixed models will be used to test the primary hypothesis that an 11-month, telephone-based patient-spouse intervention will result in a greater reduction in LDL-C as compared to printed education materials. Various process measures, including social support, self-efficacy, medication adherence, dietary behavior, and exercise, are also assessed to explain any change, or lack thereof, in LDL-C.Given the social context in which self-management occurs, interventions that teach spouses to provide instrumental and emotional support may help patients initiate and adhere to behaviors that lower their LDL-C levels. Moreover, allowing patients to retain autonomy by deciding which behaviors they would like to change and how may improve adherence and clinical outcomes.The ClinicalTrials.gov registration number is NCT00321789.

Project description:Persistent hip pain in older people is usually due to hip osteoarthritis (OA), a major cause of pain, disability, and psychological dysfunction.The purpose of this study is to evaluate whether adding an Internet-based pain coping skills training (PCST) protocol to a standardized intervention of education followed by physical therapist-instructed home exercise leads to greater reductions in pain and improvements in function.An assessor-, therapist-, and participant-blinded randomized controlled trial will be conducted.The study will be conducted in a community setting.The participants will be 142 people over 50 years of age with self-reported hip pain consistent with hip OA.Participants will be randomly allocated to: (1) a control group receiving a 24-week standardized intervention comprising an 8-week Internet-based education package followed by 5 individual physical therapy exercise sessions plus home exercises (3 times weekly) or (2) a PCST group receiving an 8-week Internet-based PCST protocol in addition to the control intervention.Outcomes will be measured at baseline and 8, 24, and 52 weeks, with the primary time point at 24 weeks. Primary outcomes are hip pain on walking and self-reported physical function. Secondary outcomes include health-related quality-of-life, participant-perceived treatment response, self-efficacy for pain management and function, pain coping attempts, pain catastrophizing, and physical activity. Measurements of adherence, adverse events, use of health services, and process measures will be collected at 24 and 52 weeks. Cost-effectiveness will be assessed at 52 weeks.A self-reported diagnosis of persistent hip pain will be used.The findings will help determine whether adding an Internet-based PCST protocol to standardized education and physical therapist-instructed home exercise is more effective than education and exercise alone for persistent hip pain. This study has the potential to guide clinical practice toward innovative modes of psychosocial health care provision.

Project description:BACKGROUND:Anxiety is a common diagnosis in children with autism spectrum disorder (ASD). One key mechanism underlying anxiety is intolerance of uncertainty, which is a tendency to react negatively on an emotional, cognitive, and behavioural level to uncertain situations and events. We developed the first intervention programme specifically targeting intolerance of uncertainty in children with ASD: Coping with Uncertainty in Everyday Situations (CUES). CUES is a parent group intervention providing parents of children with ASD with strategies to increase tolerance to uncertainty for their children in everyday situations. The principal aims of the current study are: 1) evaluate the acceptability and feasibility of delivering CUES to parents who have a child with ASD and anxiety; and 2) inform the design of a fully powered trial. METHOD:This is a feasibility and acceptability single-blind pilot randomised controlled trial comparing CUES (intervention) to a brief psychoeducation, emotional literacy, and relaxation programme (enhanced services as usual). Participants will be assessed at baseline and followed-up immediately post-treatment, and at 12 and 26 weeks post-treatment. Parents who have a child with ASD and anxiety (aged 6-16 years) will be invited to take part in the study and written parental informed consent and child assent will be obtained. Participants will be recruited from the National Health Service mental health teams in the UK. Sixty participants will be randomised to either intervention or enhanced services as usual in a 1:1 ratio. DISCUSSION:The present study will provide evidence on the acceptability of the CUES intervention to parents and children, and the feasibility of recruitment and delivery to inform the design and sample size for a full-scale randomised controlled trial. Qualitative data will be obtained to understand how feasible CUES is for families, and the experiences of participants regarding their experiences of the intervention. TRIAL REGISTRATION:ISRCTN, ISRCTN10139240 . Registered on 14 May 2018.