Breast Neoplasm Clinical Trial
Official title:
Self-care Programs in Oncology: a Guided Internet-delivered Individually-tailored Acceptance and Commitment Therapy (ACT)-Influenced Cognitive Behavioural Intervention to Improve Psychosocial Outcomes in Breast Cancer Survivors
Background: Internet-delivered interventions (IDI) can provide remarkable opportunities in
addressing breast cancer (BC) survivors' unmet needs, as they present an effective strategy
to improve care coordination and provide access to efficacious, cost-efficient and convenient
survivorship care. Nevertheless, research focusing on this field and aiming at improving
survivors´ psychosocial needs is scarce and its practical implementation is limited.
Objectives: This study aims at studying BC patients´ and healthcare providers' attitudes
towards IDI; exploring BC patients´ unmet support needs and; determining the acceptability,
feasibility, efficacy and cost-effectiveness of iACT-BC, a guided internet-delivered
individually-tailored ACT-influenced cognitive behavioural intervention designed to improve
psychosocial outcomes in BC survivors when compared to treatment as usual. The primary
outcomes in this research are anxiety and depression. Secondary outcomes include
psychological flexibility, fatigue, insomnia, Sexual dysfunction (SD) and Health Related
Quality of Life.
Methods: A multimethod research design will be applied and two consecutive studies will be
performed. Study 1 will explore participants´ attitudes towards IDI as well as, BC patients'
psychosocial unmet needs by adopting an exploratory cross-sectional study design. Study 2
will investigate the effectiveness and cost-effectiveness of iACT-BC in BC survivors, by
implementing a two-arm, parallel, open label, multicentre, waiting list randomized controlled
trial.
Expected Results: It is anticipated that iACT-BC will show to be an effective and
cost-effective program in improving anxiety, depression, psychological flexibility, fatigue,
insomnia, SD and HRQoL in BC survivors, as opposing to a waiting list control under treatment
as usual. The results of this research will be published in accordance with CONSORT 2010 and
CONSORT-EHEALTH guidelines and should be available for publication in February 2020.
Background: Breast Cancer (BC) ranks as the most frequent and lethal cancer among women, in
Portugal. However, advances in cancer detection and treatment contributed to a steady and
significant increase in survival over the past years, and 5-year age-standardized relative
survival is currently estimated to be 83,4%. This increase translates into a high and growing
number of BC survivors, with a considerable proportion of these patients experiencing
sequelae of treatment and late effects that can occur immediately to several years after
primary treatment ends. Anxiety, depression, fear of recurrence, existential related issues,
fatigue, pain, physical and cognitive impairment, tailored information needs, and sexual
dysfunction have been reported as the most common unmet support care needs experienced by
these women. The answer to these unmet support care needs relies, in part, on delivering
comprehensive, highly coordinated, patient-centred care. However, operationalizing such care
may prove difficult in a context of competing priorities and constrained health and social
care budgets. In this context, connected health, particularly internet-delivered
interventions, can provide remarkable opportunities in overcoming the aforementioned
constraints, as presenting an effective and innovative healthcare delivery model capable of
improving care coordination and providing access to efficacious, cost-efficient and
convenient survivorship care. Nevertheless, research focusing on this field and aiming at
improving survivors´ psychosocial needs is scarce and its practical implementation is
limited.
Objectives: The objectives of this investigation are: studying BC patients´ and healthcare
providers' attitudes towards internet-delivered interventions; exploring breast cancer
patients´ unmet support care needs and; determining the acceptability, feasibility,
effectiveness and cost-effectiveness of iACT-BC, a guided internet-delivered
individually-tailored Acceptance and Commitment Therapy (ACT)-influenced cognitive
behavioural intervention designed to improve psychosocial outcomes in BC survivors when
compared to treatment as usual (TAU) in a waiting list control group (WLC). The primary
outcomes in this research are anxiety and depression. Secondary outcomes include
psychological flexibility, fatigue, insomnia, sexual dysfunction and Health Related Quality
of Life (HRQoL).
Hypotheses: We hypothesize that participants in the intervention group will have improved
anxiety, depression, psychological flexibility, fatigue, insomnia, sexual dysfunction and
HRQoL, when compared to a WLC.
Methods: A multimethod research design will be applied and two consecutive studies will be
performed: Study 1 - Population characterization study and Study 2 - Efficacy and
cost-effectiveness study. Study 1 will explore participants´ attitudes towards
internet-delivered interventions as well as, BC patients' psychosocial unmet support needs by
adopting an exploratory cross-sectional study design. Study 2 will investigate the
effectiveness and cost-effectiveness of iACT-BC in BC survivors, by implementing a two-arm,
parallel, open label, multicentre, pragmatic, waiting list randomized controlled trial. A
Pilot study, mirroring the conditions applied in Study 2 should be performed in order to
evaluate the feasibility and acceptability of iACT-BC. Results from this Pilot study should
be appraised and inform execution of Study 2
Ethical approval: This study will soon be submitted to evaluation by CNPD and local ethic
committees. Authorization to run the study is expected to be received until January 2018.
Expected Results: It is anticipated that iACT-BC will show to be an effective and
cost-effective program in improving psychosocial outcomes such as anxiety, depression,
psychological flexibility, fatigue, insomnia, sexual dysfunction and HRQoL in BC survivors,
as opposing to a WLC under TAU. The results of this research will be published in accordance
with CONSORT 2010 and CONSORT-EHEALTH guidelines and should be available for publication in
February 2020.
Keywords: Breast Cancer; Survivors; Internet intervention; Psychosocial intervention;
Acceptance and Commitment Therapy (ACT); Randomized controlled trial protocol.
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