Dataset Information

A 4-Month Whole-Systems Ayurvedic Medicine Nutrition and Lifestyle Intervention Is Feasible and Acceptable for Breast Cancer Survivors: Results of a Single-Arm Pilot Clinical Trial.

ABSTRACT:

Purpose

Ongoing symptoms and impairments in quality of life (QOL) among breast cancer survivors remain a significant problem. We tested the feasibility and acceptability of a manualized Ayurvedic nutrition and lifestyle intervention for breast cancer survivors.

Methods

Eligible participants had Stage I-III breast cancer, underwent treatment within the past year that included chemotherapy, and were without active disease. The 4-month individualized Ayurvedic intervention included counseling on nutrition, lifestyle, yoga, and marma (like acupressure) during 8 one-on-one visits with an Ayurvedic practitioner. Feasibility and acceptability were the primary outcomes. QOL (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ C30]) and symptoms-sleep disturbance (General Sleep Disturbance Scale [GSDS]), fatigue (Lee Fatigue Scale [LFS]), depressive symptoms (Center for Epidemiological Studies-Depression Scale [CES-D]), anxiety (Spielberger State-Trait Anxiety Inventory [STAI-S, STAI-T]), and stress (Perceived Stress Scale [PSS])-were measured prior to, at midpoint, and at the end of the 4-month intervention. Effect sizes (Cohen's d) were calculated along with paired t tests comparing baseline to end of month 4 time points. Mixed effects models were used for repeated measures analyses.

Results

Participants (n?=?32) had a mean age of 48?years (SD?=?10). Retention at the end of the intervention was 84%. Among those who completed the intervention (n?=?27), adherence was high (99.5% of visits with practitioners attended). Large improvements were seen in QLQ-C30 emotional functioning (d?=?0.84, P?d?=?0.86, P?d?=?-1.23, P?d?=?-1.21, P?d?=?0.65, p?=?0.003), LFS (d?=?-0.68, P?=?0.002), and PSS (d?=?-0.75, P?ConclusionThis 4-month Ayurvedic whole-systems multimodal nutrition and lifestyle intervention was feasible and acceptable for breast cancer survivors. Promise of clinical benefit was seen in terms of improvements in symptoms and QOL that warrants further investigation.

SUBMITTER: Dhruva A

PROVIDER: S-EPMC7716077 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Publications

A 4-Month Whole-Systems Ayurvedic Medicine Nutrition and Lifestyle Intervention Is Feasible and Acceptable for Breast Cancer Survivors: Results of a Single-Arm Pilot Clinical Trial.

Dhruva Anand A Wu Cairn C Miaskowski Christine C Hartogensis Wendy W Rugo Hope S HS Adler Shelley R SR Kaptchuk Ted J TJ Kelkar Rucha R Agarawal Sangeeta S Vadodaria Amisha A Garris Ellen E Hecht Frederick M FM

Global advances in health and medicine 20201201

<h4>Purpose</h4>Ongoing symptoms and impairments in quality of life (QOL) among breast cancer survivors remain a significant problem. We tested the feasibility and acceptability of a manualized Ayurvedic nutrition and lifestyle intervention for breast cancer survivors.<h4>Methods</h4>Eligible participants had Stage I-III breast cancer, underwent treatment within the past year that included chemotherapy, and were without active disease. The 4-month individualized Ayurvedic intervention included c ...[more]

PMID: 33312762

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Project description:BackgroundSelf-management is recommended for patients with chronic conditions, but its use with cancer survivors is underexplored. Optimal strategies for achieving lifestyle changes in cancer survivors are not known.ObjectiveWe aimed to determine feasibility, acceptability and preliminary efficacy of self-management-based nutrition and physical activity interventions for cancer survivors.Design, setting and participantsAdult survivors (n = 25) during (Group 1 , n = 11) or post (Group 2, n = 14)-curative chemotherapy for solid tumours, most (n = 20, 80%) with breast cancer, were recruited prospectively from a single clinical centre.InterventionThe Flinders Living Well Self-Management Program, a generic self-management care planning programme, was utilized to establish patient-led nutrition and exercise goals within a tailored 12-week intervention. Fortnightly progress reviews occurred with assessments at baseline, 6 and 12 weeks.ResultsMost participants (84%) found the intervention acceptable/very acceptable. Both groups showed a trend towards significant improvement in the self-management capability 'knowledge about changing risk factors' (P = 0.047); Group 2 showed a trend towards significantly improved 'psychological impacts' (P = 0.007). Goal ratings improved for both groups (P = 0.001). Quality of life improved for both groups for emotional functioning (P = 0.03). Physical functioning improved for Group 2 (P = 0.05); however, most symptom domains worsened for Group 1, as expected given their treatment stage.Discussion and conclusionsSelf-management interventions are feasible for this population. In particular, building self-management capacity during the active phase of patients' cancer treatment provides health and psychosocial benefits. Larger randomized controlled trials are required to further determine efficacy. Further translational research is also needed to determine acceptability,feasibility, enablers and barriers for clinicians embedding this approach into routine cancer survivorship care.

Project description:OBJECTIVES:(1) Assess whether cardiac rehabilitation (CR) is a feasible and acceptable model of rehabilitation for postsurgical colorectal cancer (CRC) survivors, (2) evaluate trial procedures. This article reports the results of the first objective. DESIGN AND SETTING:A pragmatic pilot randomised controlled trial with embedded qualitative study was conducted in 3 UK hospitals with CR facilities. Descriptive statistics were used to summarise trial parameters indicative of intervention feasibility and acceptability. Interviews and focus groups were conducted and data analysed thematically. PARTICIPANTS:People with CRC were considered for inclusion in the trial if they were ? 18 years old, diagnosed with primary CRC and in the recovery period postsurgery (they could still be receiving adjuvant therapy). 31% (n=41) of all eligible CRC survivors consented to participate in the trial. 22 of these CRC survivors, and 8 people with cardiovascular disease (CVD), 5 CRC nurses and 6 CR clinicians participated in the qualitative study. INTERVENTION:Referral of postsurgical CRC survivors to weekly CR exercise classes and information sessions. Classes included CRC survivors and people with CVD. CR nurses and physiotherapists were given training about cancer and exercise. RESULTS:Barriers to CR were protracted recoveries from surgery, ongoing treatments and poor mobility. No adverse events were reported during the trial, suggesting that CR is safe. 62% of participants completed the intervention as per protocol and had high levels of attendance. 20 health professionals attended the cancer and exercise training course, rating it as excellent. Participants perceived that CR increased CRC survivors' confidence and motivation to exercise, and offered peer support. CR professionals were concerned about CR capacity to accommodate cancer survivors and their ability to provide psychosocial support to this group of patients. CONCLUSIONS:CR is feasible and acceptable for postsurgical CRC survivors. A large-scale effectiveness trial of the intervention should be conducted. TRIAL REGISTRATION NUMBER:ISRCTN63510637.

Project description:BackgroundThe World Health Organization recommends 30 min of tummy time daily for improved motor development and reduced likelihood of plagiocephaly. As only 30% of infants meet this recommendation, parents require strategies and support to increase this proportion.MethodsThe aim of this study was to determine the feasibility, acceptability, and potential efficacy of a group intervention to promote tummy time. The design is a cluster randomized controlled trial with concealed allocation, assessor blinding, and intention-to-treat analysis. Five groups of healthy infants (N = 35, baseline mean (SD) age 5.9 (2.8) weeks) and their mothers attending local mother's groups (Australia) were randomly allocated to the intervention or control group. The intervention group received group tummy time classes in addition to usual care. The control group received usual care with their child and family health nurse. Primary outcomes were intervention feasibility and acceptability. Secondary outcomes were tummy time duration (accelerometry), adherence to physical activity guidelines, head shape, and motor development. Measures were taken at baseline, post-intervention, and when infants were 6 months of age. Analyses were by linear mixed models and Cohen's d statistic.ResultsRecruitment, retention, and collection of objective data met feasibility targets. Acceptability was also met with intervention mothers reporting the information, goal planning, and handouts significantly more useful and relevant than control group mothers (p < 0.01). Moderate effect sizes were also found at post-intervention for tummy time duration, adherence to physical activity guidelines and infant ability in prone and supine favoring the intervention group (intervention infants had a mean of 30 min and 30% adherence to guidelines (95% CI 0 to 60.6 min) compared to the control infants who had a mean of 16.6 min and 13% adherence to the guidelines (95% CI 0 to 42.1 min, Cohen's d = 0.5). Limitations were the small sample size, 4-week intervention, limited accelerometer use, and a homogenous sample of participants.ConclusionGroup tummy time classes delivered in a mother's group setting were shown to be feasible and acceptable. A larger randomized controlled trial is warranted.Trial registrationANZCTR, ACTRN12617001298303p. Registered 11 September 2017.

Dataset Information

A 4-Month Whole-Systems Ayurvedic Medicine Nutrition and Lifestyle Intervention Is Feasible and Acceptable for Breast Cancer Survivors: Results of a Single-Arm Pilot Clinical Trial.

Purpose

Methods

Results

Publications

A 4-Month Whole-Systems Ayurvedic Medicine Nutrition and Lifestyle Intervention Is Feasible and Acceptable for Breast Cancer Survivors: Results of a Single-Arm Pilot Clinical Trial.

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