Integrative Approaches For Cancer Survivorship 2: Project 1 (IACS2)
1 mars 2019 uppdaterad av: University of California, San Francisco
Developing an Integrative Ayurvedic Intervention for Breast Cancer Survivorship
The purpose of this study is to develop and test a 12-month Integrative Medicine intervention based on Ayurvedic medicine in recent breast cancer survivors.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Cancer associated symptoms and impaired quality of life remain significant problems for patients despite advances in cancer treatment.
Few effective treatment options exist for these symptoms.
Integrative medicine is rising in popularity in the United States; however, few integrative medicine modalities have been rigorously studied.
Ayurveda, a whole system of medicine that originated in the Indian subcontinent, has its own system of diagnostics and therapeutics, and among its strengths are wellness and prevention.
The investigators aim to perform a prospective single arm clinical study of a manualized Ayurvedic approach in breast cancer survivors with impaired quality of life.
Specifically, the investigators aim to refine the manualized Ayurvedic intervention; to assess feasibility; and to determine whether clinically meaningful effects can be achieved with the intervention.
Studietyp
Interventionell
Inskrivning (Faktisk)
20
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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California
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San Francisco, California, Förenta staterna, 94115
- University of California, San Francisco, Osher Center for Integrative Medicine
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Kvinna
Beskrivning
Inclusion Criteria:
- Female breast cancer survivor who is over 1 month and less than 24 months beyond the completion of primary therapy (surgery, radiation, and chemotherapy)
- Having received chemotherapy as part of their primary therapy for breast cancer
- Be in complete remission
- Aged 18 years or older
- Able to read, write, and understand English
- Karnofsky Performance Status (KPS) greater than or equal to 60
- Have impaired quality of life
- Ability to give informed consent
Exclusion Criteria:
- Having received Ayurvedic treatment within 6 months of study enrollment
- Receiving chemotherapy or radiotherapy at the time of study enrollment. Anti-her2 directed therapy is not exclusionary.
- Being within 1 month (before or after) of surgery for breast cancer (including breast reconstructive surgery). Smaller surgical procedures such as implant exchange are not exclusionary.
- Patients on adjuvant hormone therapy for less than 2 months
- Have surgery for breast cancer or breast reconstructive surgery planned during the initial 6 month study period. Smaller surgical procedures such as implant exchange are not exclusionary.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: Integrative Medicine Intervention
Study participants will attend 14 visits with an integrative medicine clinician over the course of 6 months followed by a 6 month maintenance phase.
The treatment modalities employed in the study will include nutrition and lifestyle recommendations.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change in quality of life over 12 months
Tidsram: Baseline, 3 months, 6 months, 12 months
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The investigators will use the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ C30) in conjunction with a Breast Cancer-Specific Subscale (BR23) to collect data on qualify of life and cancer-related symptoms.
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Baseline, 3 months, 6 months, 12 months
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change in fatigue over 12 months
Tidsram: Baseline, 3 months, 6 months, 12 months
|
The investigators will use the Lee Fatigue Scale (LFS) to collect data on fatigue.
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Baseline, 3 months, 6 months, 12 months
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Change in sleep quality over 12 months
Tidsram: Baseline, 3 months, 6 months, 12 months
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The investigators will use the General Sleep Disturbance Scale (GSDS) to collect data on sleep disturbance.
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Baseline, 3 months, 6 months, 12 months
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Change in anxiety over 12 months
Tidsram: Baseline, 3 months, 6 months, 12 months
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The investigators will use the Spielberger State Anxiety Inventory (STAI-S) to collect data on anxiety.
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Baseline, 3 months, 6 months, 12 months
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Change in depressive symptoms over 12 months
Tidsram: Baseline, 3 months, 6 months, 12 months
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The investigators will use the Center for Epidemiological Studies - Depression Scale (CES-D) to collect data on depressive symptoms.
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Baseline, 3 months, 6 months, 12 months
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Change in pain over 12 months
Tidsram: Baseline, 3 months, 6 months, 12 months
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The investigators will use the Brief Pain Inventory (BPI) to collect data on pain intensity and interference with function.
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Baseline, 3 months, 6 months, 12 months
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Change in diet over 12 months
Tidsram: Baseline, 3 months, 6 months, 12 months
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The investigators will use the Automated Self-Administered 24-hour Recall (ASA24) to assess dietary recall over a 24 hour period.
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Baseline, 3 months, 6 months, 12 months
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
Utredare
- Huvudutredare: Anand Dhruva, MD, University of California, San Francisco
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 september 2016
Primärt slutförande (Faktisk)
21 september 2018
Avslutad studie (Faktisk)
21 september 2018
Studieregistreringsdatum
Först inskickad
7 september 2016
Först inskickad som uppfyllde QC-kriterierna
7 september 2016
Första postat (Uppskatta)
13 september 2016
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
5 mars 2019
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
1 mars 2019
Senast verifierad
1 mars 2019
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 16-18567
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .