Clinical trial NCT04905576: Quality of Life Interventions During Cervical Cancer Treatment
Official title: Quality of Life Interventions During Cervical Cancer Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Cancer
Keywords: cervical cancer
healing touch
healing touch therapy
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2021-05-27
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients are randomized to relaxation, healing touch, or standard care arms of the study
Primary purpose: SUPPORTIVE_CARE

Brief summary: The proposed project will examine the effects of a healing touch intervention in women receiving chemotherapy and radiation for advanced cervical cancer.

Detailed description: Patients receiving chemoradiation for cervical cancer are at risk for distress, chemoradiation-related side effects, and immunosuppression. This prospective randomized clinical trial proposes to examine the effects of a complementary therapy, Healing Touch (HT), versus relaxation training (RT) and usual care (UC) for (1) supporting cellular immunity, (2) improving mood and quality of life (QOL), and (3) reducing treatment-associated toxicities and treatment delay in cervical cancer patients receiving chemoradiation.

Eligibility criteria: Inclusion Criteria:

* Women with stage I-IVa cervical cancer pursuing concurrent chemotherapy and radiation therapy.

Exclusion Criteria:

* Greater than Stage IVa cervical cancer
* Metastatic or recurrent cervical cancer
* Patients receiving only chemotherapy or only radiation therapy
* History of cancer of any site
* History of a transplant
* Diagnosed with any immunosupressive disorder (HIV, AIDS).

Primary outcomes:
measure: Change in natural killer cell cytotoxicity (NKCC)
timeFrame: 6 weeks
measure: Number of chemoradiation-related toxicities
timeFrame: 6 weeks
measure: Number of days of treatment delay due to chemoradiation-related toxicities
timeFrame: 6 weeks
measure: Change in participant reports of depression
timeFrame: 6 weeks
Secondary outcomes:
measure: Change in participant reports of anxiety
timeFrame: 6 weeks
measure: Change in white blood cell counts
timeFrame: 6 weeks
measure: Change in red blood cell counts
timeFrame: 6 weeks
measure: Change in participant reports of quality of life
timeFrame: 6 weeks
measure: Change in participant reports of fatigue
timeFrame: 6 weeks
measure: Change in metabolomic measures
timeFrame: 6 weeks
Other outcomes:
Locations:
Study officials:
affiliation: University of Iowa
name: Susan Lutgendorf, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lutgendorf SK, Mullen-Houser E, Russell D, Degeest K, Jacobson G, Hart L, Bender D, Anderson B, Buekers TE, Goodheart MJ, Antoni MH, Sood AK, Lubaroff DM. Preservation of immune function in cervical cancer patients during chemoradiation using a novel integrative approach. Brain Behav Immun. 2010 Nov;24(8):1231-40. doi: 10.1016/j.bbi.2010.06.014. Epub 2010 Jun 30.
citation: Hart LK, Freel MI, Haylock PJ, Lutgendorf SK. The use of healing touch in integrative oncology. Clin J Oncol Nurs. 2011 Oct;15(5):519-25. doi: 10.1188/11.CJON.519-525.